Northwestern University Feinberg School of Medicine

CORE C ā€“ Clinical & Translational Core

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Our Mission

Core Cā€™s Mission

  • Provide support for research study design and conduct
  • Offer assistance with data management and data analysis
  • Aid in application of methodologies in statistics, patient-reported outcomes and biomedical informatics
  • Facilitate access to and expand existing data and biosample repositories
  • Promote a research environment that more fully engages in the community and that is deeply committed to maintaining the highest ethical standards for human subjects research

Core C Services

Research study design and conduct
Access to existing data and biosample repositories
Data management and data analysis
Community engagement and research bioethics
Application of methodologies in statistics, patient-reported outcomes and biomedical informatics

Active Human Research Studies

  • Transformative Research in Diabetic Nephropathy (TRIDENT) Study (STU00204808)
    The TRIDENT study is a multi-center observational study recruiting diabetic patients who are scheduled for a native kidney biopsy and requesting an extra kidney tissue sample at the time of biopsy. If participants are confirmed to have diabetic kidney disease, they will be asked to come in for study visits every 6 months, at which point blood, urine, and medical history information will be collected.
  • Peritoneal Dialysis Practice Patterns Study 2 (PDOPPS 2) (STU00207081)
    PDOPPS 2 is an internationalsociobehavioral 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.
    The study is looking to recruit 10,000 participants overall, and approximately 45 participants at Northwestern University. The duration of study participation is approximately 3 years and includes 4 study visits. The study visits consist of completing 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.
  • Lab 23 (STU00201546)
    Lab 23 is a single-center biorepository study with a recruitment goal of600 participants (300 CKD patients and 300 healthy volunteers). 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.
  • Decision Aid for Renal Therapy (DART): Promoting Knowledge and Autonomy in Chronic Kidney Disease Patients and Their Care-Partners Study (STU00207013)
  • CALISTA Study (STU00207396)
    A multi-center, Phase 3, Randomized, Double-blind, Placebo-controlled study using Intravenous Sodium Thiosulfate for Acute Calciphylaxis Treatment.
  • HOPE003 (STU00207396)
    This is an 8-week observational study of up to the 111 patients who participate in the CALISTA study (A Phase 3, Intravenous Sodium Thiosulfate for Acute Calciphylaxis Treatment: A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial). This study aims to record the occurrence of delayed adverse events, standard of care treatments for calciphylaxis (medications `{`including Sodium Thiosulfate Injection and pain medication`}`, wound debridement, amputation, hyperbaric oxygen therapy, and surgical parathyroidectomy), and calciphylaxis-related complications (new or worsening skin lesions, ulceration, infection, sepsis and hospitalizations) during the 8-week observation period following patient participation in the ST-001 CALISTA study.
  • Effects of Intravenous Iron on Phosphorus and FGF23 levels (STU00203065)
    This is a single-center, observational, 6-8 –week, study on patients with iron deficiency anemia to determine the effect of treating iron deficiency anemia with intravenous ferric carboxymaltose therapy on FGF23 and phosphorus levels. A single dose of ferric carboxymaltose has been shown to increase FGF23 levels in the short-term, but the long-term effects of ferric carboxymaltose on FGF23 levels in iron deficient patients are not known. The study aims to understand the effects of intravenous ferric carboxymaltose therapy on blood levels of FGF23 in individuals with iron deficiency anemia. The information gained from this study could be used to improve the health of patients with iron deficiency anemia.
  • CEUS – Renal Microvascular Perfusion (STU00206894)
    This is a single-center prospective study to evaluate the association of renal microvascular perfusion with renal function and histopathology. Renal microvascular perfusion will be assessed by contrast-enhanced ultrasound (CEUS) using the microbubble contrast agent Lumason® (sulfur hexafluoride lipid microspheres). To quantify renal microvascular perfusion, we will perform image analysis on the enhanced images to generate time-intensity curves to calculate renal microvascular perfusion metrics.
    The recruitment goal is 200 participants for all 3 aims, which is expected to be reached within 5 years from the start of recruitment. Study participation duration is 2 years, and it includes 5 study visits. The contrast-enhanced ultrasound scan occurs at the second visit. Blood, urine, medical history, and demographic information are collected throughout the study.
  • Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Non-Dialysis (ASCEND-ND) Study
  • Controlled Trial Evaluating Avacopan in C3 Glomerulopathy
  • Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients with Primary Focal Segmental Glomerulosclerosis (FSGS) DUPLEX Study

Meet Our Navigators

Butt, Zeeshan Ahmad

Zeeshan Ahmad Butt, PhD

  • Associate Professor of Medical Social Sciences, Psychiatry and Behavioral Sciences and Surgery (Organ Transplantation)
  • z-butt( at )
Cai, Shelly

Shelly Cai

  • Statistical Analyst/Programmer
Friedewald, John J

John J Friedewald, MD

  • Professor of Medicine (Nephrology and Hypertension) and Surgery (Organ Transplantation)
  • jfriedewald( at )
Ho, Bing

Bing Ho, MD, MPH

  • Associate Professor of Medicine (Nephrology and Hypertension) and Surgery (Organ Transplantation)
  • bing-ho( at )
Lee, Jungwha

Jungwha Lee, PhD

  • Associate Professor of Preventive Medicine (Biostatistics)
  • jungwha-lee( at )
Martinez, Carlos

Carlos Martinez

  • CCRP, CTMH Clinical Research Project Manager
  • carlos.martinez( at )
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