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Clinical Trials

The following searchable list includes all the clinical trials currently looking for participants. Please feel free to contact us with inquiries about any of our ongoing research.

Trials
A PHASE 3 SINGLE CENTER STUDY OF ISLET TRANSPLANTATION IN NON-UREMIC DIABETIC PATIENTS
Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells are destroyed, resulting in poor blood sugar control. The purpose of this study is to determ…
Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells are destroyed, resulting in poor blood sugar control. The purpose of this study is to determine the safety and effectiveness of islet transplantation, combined with immunosuppressive medications, specifically using Campath as induction, for treating type 1 diabetes in individuals experiencing hypoglycemia unawareness and severe hypoglycemic episodes.
Borja-Cacho, DanielBorja-Cacho, Daniel
NCT01897688 STU00059469
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1-855-NU-STUDY
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Chronic Kidney Disease Research Biorepository
The objective of this study is to create a biorepository of stored blood and urine specimens and demographic and clinical data collected from patients with chronic kidney disease and healthy volunteers for use in chronic kidney disease research
Isakova, TamaraIsakova, Tamara
  • Map it 633 N. St. Clair St.
    Chicago , IL
STU00201546
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Martinez, Carlos 312 503 1808
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A phase 3 randomized, open-label (sponsor-blind), activecontrolled, parallel-group, multi-center, event driven study in non-dialysis subjects with anemia associated with chronic kidney disease to evaluate the safety and efficacy of daprodustat compared to darbepoetin alfa.
This is a phase III study …
This is a phase III study in non-dialysis subjects with anemia associated chronic kidney disease to evaluate the safety and efficacy of an investigational drug, Daprodustat when compared to darbepoetin alfa.
Inclusion Criteria:1. Men or Women 18 to 99 years of age.2. Chronic Kidney Disease Stages 3, 4, or 53. Acceptable if on Erythropoietin-Stimulating Agents4. Hemoglobin between 8 to 12 g/dL5. Willingness to participate and capable of giving signed informed consent.Exclusion Criteria: 1. Currently receiving dialysis2. Planned kidney transplant within 1 year 3. Iron deficient4. Other causes of anemia (pernicious anemia, thalassemia major, sickle cell, myelodysplastic syndrome)5. Uncontrolled high blood pressure6. History of malignancy within 2 years 7. Unstable liver disease8. Chronic Class IV heart failure
Ghossein, CybeleGhossein, Cybele
  • Map it 675 N. Saint Clair St. Seventeenth Floor, Suite 250
    Chicago, IL
NCT02876835 STU00203935
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Napoli, Sara 312 503 3865
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Transformative Research In Diabetic Nephropathy (TRIDENT) (SP0043185)
This is a prospective, observational, cohort study of patients with a clinical diagnosis of diabetes who are undergoing clinically indicated kidney biopsy. The intent is to collect, process, and study kidney tissue and to harvest b…
This is a prospective, observational, cohort study of patients with a clinical diagnosis of diabetes who are undergoing clinically indicated kidney biopsy. The intent is to collect, process, and study kidney tissue and to harvest blood, urine and genetic materials to elucidate molecular pathways and link them to biomarkers that characterize those patients have a rapid decline in kidney function (> 5 mL/min/1.73m2/year) from those with lesser degrees of kidney function change over the period of observation. High through-put genomic analysis associated with genetic and biomarker testing will serve to identify key potential therapeutic targets for DKD by comparing patients with rapid and slow progression patterns. Each participating clinical site will search for, consent, harvest the biopsy sample, and enroll the participants as required for the TRIDENT protocol.
Inclusion Criteria
• Type 1 and 2 Diabetes by ADA criteria (see appendix )
• Willingness to comply with study requirements, including intention to fully participate in protocol-specified follow-up at a clinical study site
• Able to provide informed consent
• Adult participants (no age restriction)
• Planned medically indicated kidney biopsy, prescribed by a practicing nephrologist
Exclusion Criteria
• ESRD, defined as chronic dialysis or kidney transplant
• History of receiving dialysis for more than 30 days
• Institutionalized
• Solid organ or bone marrow transplant recipient at time of first kidney biopsy
• Less than 3-year life expectancy
• Known alcohol or substance abuse
• Unable to provide informed consent
• No evidence of active cancer other than non-melanoma skin cancer
Isakova, TamaraIsakova, Tamara
  • Map it 633 N. St. Clair St.
    Chicago , IL
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02986984 STU00204808
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Martinez, Carlos 312 503 1808
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A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Avacopan (CCX168) in Patients with C3 Glomerulopathy
C3 glomerulopathy (C3G) is characterized by evidence of alternative complement activation based on C3 deposition in the glomeruli. There are two for…
C3 glomerulopathy (C3G) is characterized by evidence of alternative complement activation based on C3 deposition in the glomeruli. There are two forms of the disease: dense deposit disease (DDD) and C3 glomerulonephritis (C3GN). There is no approved treatment for patients with C3G. This is a randomized, double blind, placebo controlled Phase 2 study to evaluate the safety and efficacy of avacopan (CCX168) in patients with C3G. The primary objective is to evaluate the efficacy of avacopan compared to placebo based on histologic changes in kidney biopsies taken before and during treatment.
Inclusion Criteria:
1. Biopsy-proven C3G, either DDD or C3GN, with or without a renal transplant, within 12 weeks prior to screening or during screening:
2. Male or female subjects, aged at least 18 years
3. Female subjects of childbearing potential may participate if adequate contraception is used during, and for at least the three months after study completion; Male subjects with partners of childbearing potential may participate in the study if they had a vasectomy at least 6 months prior to randomization or if adequate contraception is used during, and for at least the 3 months after study completion;
4. Willing and able to give written Informed Consent and to comply with the requirements of the study protocol
5. Judged to be otherwise fit for the study by the Investigator, based on medical history, physical examination, and clinical laboratory assessments.
Exclusion Criteria:
1. Pregnant or nursing;
2. Secondary C3 disease
3. History or presence of any form of cancer within the 5 years prior to screening,
4. Currently on dialysis or will require dialysis wtihin 7 days of screening
5. Positive hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) viral screening test indicative of acute or chronic infection;
6. Evidence of tuberculosis
7. Evidence of liver disease
Ghossein, CybeleGhossein, Cybele
NCT03301467 STU00206182
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Napoli, Sara 312 503 3865
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A Randomized, Multicenter, Double-Blind, Parallel, Active-Control Study of the Effects of Sparsentan, A Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients with Primary Focal Segmental Glomerulosclerosis
This is a randomized, multicenter, double-blind, parallel, a…
This is a randomized, multicenter, double-blind, parallel, active-control study. The investigational drug (sparsentan) is a dual acting angiotensin receptor blocker and endothelin receptor agonist. The active control is irbesartan. Patients who meet eligibility criteria will require wash out from renin-angiotensin-aldosterone system (RAAS) blockers, if applicable prior to their first dose of study drug. Patients will be randomly assigned in a 1:1 ratio to receive either sparsentan or active control (irbesartan).
Inclusion Criteria:
1. Primary FSGS
2. Male or Female aged 18-75 years
3. Urine protein/creatinine ratio ≥ 1.5 g/g
4. Estimated glomerular filtration rate (eGFR) ≥ 30
5. Blood pressure criteria:  ≥100/60 mmHg and ≤160/100 mmHg
6. Women of child bearing potential must agree to the simulataneous use of 2 medically accepted methods of contraception from randomization until 90 days after the last dose of study medication. Males, unless surgically sterile, must agree to use highly reliable methods of contraception from randomization until 90 days after the last dose of study medication.
Exclusion Criteria:
1. Secondary FSGS
2. History of type 1 diabetes, uncontrolled type 2 diabetes, organ transplantation, heart failure (Class II-IV), malignancy, significant valvular disease, or alcohol/substance abuse.
3. History of significant cerebrovascular disease and/or coronary artery disease within 6 months
4. Body Mass Index (BMI) > 40
3. Females who are pregnant, plan to become pregnant through the course of the study, or are breastfeeding. Males who plan to father a child during the course of the study.
Ghossein, CybeleGhossein, Cybele
NCT03493685 STU00206193
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Napoli, Sara 312 503 3865
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Protocol Dialysis Outcomes and Practice Patterns Study 2
The Peritoneal Dialysis Outcomes and Practice Patterns Study 2 (PDOPPS 2) is a sociobehavioral research study seeking to identify and analyze the links between modifiable dialysis practices and health outcomes in patients receiving (or planning…
The Peritoneal Dialysis Outcomes and Practice Patterns Study 2 (PDOPPS 2) is a sociobehavioral research study seeking to identify and analyze the links between modifiable dialysis practices and health outcomes in patients receiving (or planning to receive) chronic Peritoneal Dialysis (PD). The overarching goal of the study is to extend patient survival and improving quality of life for PD patients. There is no intervention being utilized as part of this research, participants will not incur charges as a result of study participation, and participants will not receive any financial compensation for participation in the study. Study participation consists of completing a patient questionnaire that asks about how kidney disease affects well-being and overall quality of life and extraction of data , by the study team, from a participant's medical record to complete other questionnaires associated with overall health. The duration of study participation is approximately 3 years and includes 4 study visits. The study visits consist of completing the an optional patient questionnaire on a yearly basis. The questionnaire will be completed when participants are seen in the dialysis clinic. Individuals can still choose to participate without having to complete the patient questionnaire.
Inclusion Criteria
• 18 years of age or older
• Treated at a Peritoneal Dialysis facility
• Receiving chronic, maintenance Peritoneal Dialysis provided by the facility but independent of the facility (for example., at home or a nursing home facility)
• Incident patients must have initiated Peritoneal Dialysis within 60 days of the first Peritoneal Dialysis treatment at home/nursing home

Exclusion Criteria
• Less than 18 years of age
• Receiving Peritoneal Dialysis for acute renal failure
• Receiving concomitant Peritoneal Dialysis and Hemodialysis (hybrid therapy) *
• Adults unable to consent/Cognitively impaired
• Pregnant women
• Prisoners or other detained individuals
* Hybrid therapy will be excluded from sampling for incident patients only but will be included in prevalent patient sampling
Isakova, TamaraIsakova, Tamara
  • Map it 633 N. St. Clair St.
    Chicago , IL
  • Map it 201 E. Huron St.
    Chicago, IL
STU00207081
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For more information on this study please contact us:

Martinez, Carlos 312 503 1808
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EMPA-KIDNEY Trial - A multicentre international randomized parallel group double-blind placebocontrolled clinical trial of EMPAgliflozin once daily to assess cardio-renal outcomes in patients with chronic KIDNEY disease
EMPA-KIDNEY is a clinical trial evaluating the effects of empagliflozin on cardio…
EMPA-KIDNEY is a clinical trial evaluating the effects of empagliflozin on cardiovascular health and progression of chronic kidney disease. This research is studying patients with chronic kidney disease (both with and without diabetes). The study involves taking the study medication every day for about 3-4 years. Additionally, the study team will ask participants to come for study visits, with 3 visits in the first 6 months and then one visit every 6 months until the end of the study. Visits will include surveys, blood and urine collection, and distribution of study medication.
Age is ≥ 18 years at Screening;

There is evidence of chronic kidney disease at risk of kidney disease progression;

A local Investigator judges that the participant neither requires empagliflozin (or any other SGLT-2 or SGLT -1/2 inhibitor), nor that such treatment is inappropriate;

none of the exclusion criteria apply

Isakova, TamaraIsakova, Tamara
  • Map it 633 N. St. Clair St.
    Chicago , IL
NCT03594110 STU00208411
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Martinez, Carlos +1 312 503 1808
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GDCN Clinical Center: Advancing Clinical Research in Primary Glomerular Diseases (Cure Glomerulonephropathy Network (CureGN))
The core CureGN study is a multi-center prospective cohort study of approximately 2400 adult and pediatric patients with biopsy-documented IgAN, FSGS, MN, and MCD.  For e…
The core CureGN study is a multi-center prospective cohort study of approximately 2400 adult and pediatric patients with biopsy-documented IgAN, FSGS, MN, and MCD.  For each disease category, approximately 600 patients will be recruited.  Participants meeting the enrollment criteria will be enrolled if they or their legally authorized representative provide informed consent.  Participants will be followed until death, withdrawal from the study, or end of the study.  
Inclusion Criteria :

1)Diagnosis of MCD, FSGS, MN, or IgAN on first diagnostic kidney biopsy, as per specified pathology definitions

2)First diagnostic kidney biopsy within 5 years of study enrollment

3)Access to first kidney biopsy report and/or slides

Exclusion Criteria

1)ESKD/ESRD, defined as chronic dialysis or kidney transplant

2)Institutionalized

3)Solid organ or bone marrow transplant recipient at time of first kidney biopsy

4)Diagnosis of any of the following at the time of biopsy

-Diabetes Mellitus

-Systemic Lupus Erythematosus

-HIV

-Active malignancy, except for non-melanoma skin cancer

-Active Hepatitis B or C infection, defined as positive viral load

Wadhwani, ShikhaWadhwani, Shikha
  • Map it 201 E. Huron St.
    Chicago, IL
STU00208760
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Fox, Patrick +1 312 503 1887
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A Randomized, Double-Blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients with Primary IgA Nephropathy At Risk Of Progressing to End-Stage Renal Disease (NefIgArd)

The overall aim of this phase III, randomized, double-blind,placebo-controlled study is to evaluate …

The overall aim of this phase III, randomized, double-blind,placebo-controlled study is to evaluate the efficacy, safety, and tolerabilityof Nefecon 16 mg per day in the treatment of patients with primaryImmunoglobulin A nephropathy at risk of progressing to end-stage renal diseasedespite maximum tolerated treatment with renin-angiotensin system blockadeusing angiotensin converting enzyme inhibitors or angiotensin II type Ireceptor blockers. The study will consist of 2 parts. Part A will includea 9 month blinded Treatment Period, and a 3-month Follow up Period. Part B willconsist of an observational Long-term Follow up Period in which the patientswill be followed until 100 clinical events, measured as reduction in eGFRcompared to baseline.

Inclusion Criteria:

  • Female or male patients ≥18 years
  • Biopsy-verified IgA nephropathy
  • Stable dose of RAS inhibitor therapy (ACEIs and/or ARBs) at the maximum allowed dose or Maximum Tolerated Dose (MTD) according to the 2012 KDIGO (Kidney Disease: Improving Global Outcomes) guidelines
  • Urine protein creatinine ratio ≥1 g/24hr
  • eGFR ≥45 mL/min per 1.73 m2 and ≤90 mL/min per 1.73 m2 using the Chronic Kidney Diseae Epidemiology Collaboration (CKD-EPI) formula
  • Willing and able to give informed consent
  • Exclusion Criteria:

  • Systemic diseases that may cause mesangial IgA deposition.
  • Patients who have undergone a kidney transplant.
  • Patients with acute or chronic infectious disease including hepatitis, tuberculosis, human immunodeficiency virus (HIV), and chronic urinary tract infections.
  • Patients with liver cirrhosis, as assessed by the Investigator.
  • Patients with a diagnosis of type 1 or type 2 diabetes mellitus which is poorly controlled.
  • Patients with history of unstable angina, class III or IV congestive heart failure, and/or clinically significant arrhythmia, as judged by the Investigator;
  • Patients with unacceptable blood pressure control defined as a blood pressure consistently above national guidelines for proteinuric renal disease, as assessed by the Investigator
  • Patients with diagnosed malignancy within the past 5 years.
  • Wadhwani, ShikhaWadhwani, Shikha
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03643965 STU00207093
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    Fox, Patrick +1 312 503 1887
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    A Phase 2, Randomized, Double-blind, Placebo-controlled Evaluation of the Safety and Efficacy of BMS-986165 with Background Treatment in Subjects with Lupus Nephritis
    The "Paisley" study for Lupus Nephritis is a research study that is evaluating an oral investigational drug for people with moderate t…
    The "Paisley" study for Lupus Nephritis is a research study that is evaluating an oral investigational drug for people with moderate to severe lupus nephritis. 

    Inclusion Criteria:

    • Meets the Systemic Lupus International Collaborating Clinics (SLICC) classification criteria for SLE and diagnosed ≥ 24 weeks before the screening visit
    • One of the following: antinuclear antibody (ANA) ≥ 1:80 or positive anti-double-stranded DNA (dsDNA) or positive anti-Smith (Sm)
    • Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥ 6 points and clinical SLEDAI-2K score ≥ 4 points

    Exclusion Criteria:

    • Subjects with drug-induced SLE, certain other autoimmune diseases, and active, severe lupus nephritis
    • SLE overlap syndromes such as scleroderma and mixed connective tissue disease
    • Clinically significant abnormalities on chest x-ray or ECG
    • History of any significant drug allergy

    Other protocol defined inclusion/exclusion criteria could apply

    Wadhwani, ShikhaWadhwani, Shikha
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03943147 STU00210122
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    Fox, Patrick +1 312 503 1887
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    An Open-Label Dose-Exploration Cohort Study Evaluating the Efficacy and Safety of Voclosporin in Achieving Complete or Partial Remission of Proteinuria in Subjects with Focal Segmental Glomerulosclerosis
    The aim of the this study to assess the efficacy of voclosporin in achieving complete or partial …
    The aim of the this study to assess the efficacy of voclosporin in achieving complete or partial remission of proteinuria after 24 weeks of therapy in subjects with focal segmental glomerulosclerosis (FSGS). As well as to assess the safety and tolerability of voclosporin over 24 weeks in subjects with FSGS.

    Inclusion Criteria:

  • Primary FSGS diagnosed by renal biopsy within 6 months prior to end of screening.
  • At initial screening assessment and at last qualifying assessment during screening period prior to baseline, FSGS subjects must have urine protein creatinine ratio (UPCR) ≥2.0 mg/mg, serum albumin ≥3.2 g/dL. Subjects can be treatment-naïve or receiving steroid treatment (oral or IV) for FSGS. Subjects taking steroids must show signs of improvement in proteinuria, defined as at least a 20% improvement in UPCR from initiation of steroids to the last stability assessment prior to baseline. Subjects who have discontinued steroid treatment due to poor tolerability may be considered for the study.
  • Stable proteinuria, renal function, and BP for at least 2 weeks prior to baseline, as assessed by the Investigator. Substantial changes in UPCR, estimated glomerular filtration rate (eGFR), and/or BP during the screening period may be due to treatments administered (e.g., ACEIs and ARBs); and, therefore, may interfere with study assessments or outcomes, or may place the subject at increased risk. These subjects must be discussed with the medical monitor prior to initiation of study treatment.
  • Exclusion Criteria:

  • Clinical or histologic evidence of secondary FSGS.
  • Histologic evidence of collapsing variant FSGS.
  • eGFR as calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation of ≤30 mL/minute/1.73 m2 at initial screening assessment or ≤45 mL/minute/1.73 m2 at last qualifying assessment during screening period prior to baseline.
  • Currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period.
  • Current or medical history of:

    • Congenital or acquired immunodeficiency.
    • In the opinion of the Investigator, clinically significant drug or alcohol abuse within 2 years prior to screening.
    • Malignancy within 5 years of screening, with the exception of basal and squamous cell carcinomas treated by complete excision. Subjects with cervical dysplasia that is cervical intraepithelial neoplasia 1, but have been treated with conization or loop electrosurgical excision procedure and have had a normal repeat Papanicolaou test are allowed.
    • Current or past lymphoproliferative disease or previous total lymphoid irradiation.
    • Severe viral infection (e.g., cytomegalovirus, hepatitis B virus, hepatitis C virus) within 3 months of screening, or known HIV infection. Severe viral infection is defined as active disease requiring antiviral therapy.
    • Active tuberculosis (TB) or known history of TB/evidence of old TB if not taking prophylaxis with isoniazid.
  • Wadhwani, ShikhaWadhwani, Shikha
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03598036 STU00209338
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    Fox, Patrick +1 312 503 1887
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    A Study of the Natural History of Leukocyte Chemotactic Factor 2 Amyloidosis (ALECT2) Disease
    This natural history study will observe and collect information on people whohave ALECT2. A natural history studymeans that there are no changes to the a participant's standard of care or the routinemanageme…
    This natural history study will observe and collect information on people whohave ALECT2. A natural history studymeans that there are no changes to the a participant's standard of care or the routinemanagement of a disease. This natural history study aims to better understandwhy ALECT2 develops, and what happens to people with ALECT2 over time. If we understand more aboutALECT2 and how it affects the body over time, we may be able to establish newways to diagnose and treat the condition. Eligible participants are askedto complete study visits every 6 months for up to 4 years. At the study visits, participants will have a physicalexam, give blood and urine samples, complete questionnaires, and have tests tomeasure their heart and kidney function.
    • Age 18 or older
    • Renal biopsy with proven ALECT2 diagnosis OR kidney disease with suspicion for ALECT2 diagnosis
    Aggarwal, VikramAggarwal, Vikram
    • Map it 675 N. Saint Clair St.
      Chicago, IL
    STU00210666
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    Carns, Mary +1 312 503 1137
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