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If you have any questions or are interested in participating in a clinical trial, please call 1-866-462-9371 or send an e-mail to kidneytrials@unc.edu

Are you interested in participating in a clinical trial?

View UNC Kidney studies at Research for Me (UNC based website)

View trials all over the country for nephrotic syndrome at Kidney Health Gateway

Are you interested in referring a patient for a clinical trial?

View Current Clinical Trials 

What is a Clinical Trial?

In clinical trials, researchers test new ways to prevent, detect, or treat disease. Treatments might be new drugs or combinations of drugs, new surgical procedures or devices, or new ways to use existing treatments. Clinical trials can also test other aspects of care, such as ways to improve the quality of life for people with chronic illnesses.

A well-designed clinical trial is the gold standard for proving that a treatment or medical approach works, but clinical trials can’t always be used. For example, scientists can’t randomly assign people to live in different places, or ask people to start smoking or eating an unhealthy diet. Clinical trials are conducted in phases:

Phase I: Find out whether a medical approach (e.g., drug, diagnostic test, device) is safe, identify side effects, and figure out appropriate doses. Typically fewer than 100 subjects.

Phase II: Start testing whether a medical approach works. Continue monitoring for side effects; get information that goes into designing a large, phase III trial. Typically 100-300 subjects.

Phase III: Prove whether a medical approach works; continue monitoring side effects. May enroll as many subjects as needed – can be 1,000 or more.

Phase IV: When a medical approach is being marketed, continue gathering information on its effects. May enroll thousands of subjects.

SOURCE

Resources

Learn more about research at UNC: https://researchforme.unc.edu/index.php/learn
Printable Questions to ask about the research study: https://researchforme.unc.edu/index.php/learn

 

Current Trials at UNC

Click on the names below to read more about current clinical trials.
ANCA Vasculitis (Anti-neutrophil cytoplasmic antibody)

CD5 WATCH: Tailoring Maintenance Therapy to Cluster of Differentiation 5 Positive (CD5+) Regulatory B Cell Recovery in ANCA Vasculitis

Principal Investigator
Vimal Derebail, MD
vimal_derebail@med.unc.edu

Study Coordinators
Anne Froment, MSW
anne_froment@med.unc.edu

Research for Me: studies.unc.edu/18-2015
Clinical Trials.gov Link: https://clinicaltrials.gov/ct2/show/NCT03906227 

Anti-GBM (Goodpasture Disease)

GOOD-IDES-02: A Study With Imlifidase in Anti-GBM Disease (Goodpasture Disease)

Principal Investigator
Vimal Derebail, MD
vimal_derebail@med.unc.edu

Study Coordinators
Anne Froment, MSW
anne_froment@med.unc.edu

Research for Me: studies.unc.edu/22-1821
Clinical Trials.gov Link: https://clinicaltrials.gov/ct2/show/NCT05679401

CKD (Chronic Kidney Disease)

AMPLITUDE: Study of VX-147 in Adults with APOL1-Mediated Proteinuric Kidney Disease
Phase 2/3 adaptive trial

Principal Investigator
Vimal Derebail, MD
vimal_derebail@med.unc.edu

Study Coordinator
Sharia Warren
sharia_warren@med.unc.edu

Research for Me: studies.unc.edu/22-0798
Clinical Trials.gov Link:  https://clinicaltrials.gov/ct2/show/NCT05312879


Transforming Hemodialysis-Related Vascular Access Education (THRiVE)

Principal Investigator
Jennifer (Jenny) Flythe, MD
jenny_flythe@med.unc.edu

Study Coordinator
Shivani Surati
Shivani_Surati@med.unc.edu

Clinical Trials.gov Link – Adults: https://clinicaltrials.gov/study/NCT05997875

Diabetic Kidney Disease

Dialysis

Comparative Effectiveness of an Individualized Model of Hemodialysis versus Conventional Hemodialysis (Two Plus Trial)

Principal Investigator
Jenny Flythe
jenny_flythe@med.unc.edu

Study Coordinators
Amanpreet Singh
aksingh8@ad.unc.edu

Study Website: https://twoplustrial.org/home
Clinical Trials.gov Link:  https://classic.clinicaltrials.gov/ct2/show/NCT05828823

FSGS (Focal Segmental Glomerulosclerosis)

Treatment of Drug-resistant FSGS Using the LIPOSORBER® LA-15 System in Adults and Children
Post-Approval

Principal Investigator
Koyal Jain, MD
koyal_jain@med.unc.edu 

Study Coordinators 
Anne Froment, MSW
anne_froment@med.unc.edu

Research for Me: https://researchforme.unc.edu/index.php/en/study-details?rcid=198
Clinical Trials.gov Link – Adults: https://clinicaltrials.gov/ct2/show/NCT04065438
Clinical Trials.gov Link – Pediatrics: https://clinicaltrials.gov/ct2/show/NCT02235857

IgA Nephropathy (IgAN)

Kidney Transplant Recipient

The EFfect of FinErenone in Kidney TransplantiOn Recipients: The EFFEKTOR Study
Phase 2 Trial

Principal Investigator
Amy Mottl
amy_mottl@med.unc.edu

Study Coordinators
Sara Kelley
sara_kelley@med.unc.edu

Research for Me: https://researchforme.unc.edu/index.php/en/study-details?rcid=4191
Clinical Trials.gov Link:  https://classic.clinicaltrials.gov/ct2/show/NCT06059664

Lupus Nephritis

MiSLE: A Phase 2 sequential dose-escalation study evaluating the safety and feasibility of allogeneic umbilical cord derived mesenchymal stromal cells (MSC) for the treatment of adults with treatment refractory lupus
Phase 2 Trial

Principal Investigator
Saira Sheikh, MD
szsheikh@email.unc.edu

Study Coordinators
Julie Walker
julie_walker@med.unc.edu 

Clinical Trials.gov Link: https://clinicaltrials.gov/ct2/show/NCT02633163 

 

Membranous Nephropathy

REBOOT: Efficacy of Belimumab and Rituximab Compared to Rituximab Alone for the Treatment of Primary Membranous Nephropathy (ITN080AI)
Phase 2 Trial

Principal Investigator
Vimal Derebail, MD
vimal_derebail@med.unc.edu

Study Coordinators
Anne Froment, MSW
anne_froment@med.unc.edu 

Research for Me: https://researchforme.unc.edu/index.php/en/study-details?rcid=253
Clinical Trials.gov Link: https://clinicaltrials.gov/ct2/show/NCT03949855

Nephrotic Syndrome

INShore: A Study to Evaluate the Efficacy and Safety of Obinutuzumab Versus MMF in Participants With Childhood Onset Idiopathic Nephrotic Syndrome

Principal Investigator
Keisha Gibson, MD
Keisha_gibson@med.unc.edu

Study Coordinators
Jasmine Durham
jrdurham@email.unc.edu

Research for Me:
Clinical Trials.gov Link: https://clinicaltrials.gov/ct2/show/NCT05627557

Pediatric Glomerular Disease

EPPIK Study: A Phase 2, Open-Label, Single-Arm, Cohort Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Sparsentan Treatment in Pediatric Subjects with Selected Proteinuric Glomerular Diseases

Principal Investigator
Keisha Gibson, MD
keisha_gibson@med.unc.edu

Study Coordinators
Jasmine Durham
jrdurham@email.unc.edu

Clinical Trials.gov Link: https://clinicaltrials.gov/ct2/show/NCT05003986

 

VOCAL: A Double-Blind, Placebo-Controlled, Dose Escalation Study to Assess the Efficacy, Safety and Pharmacokinetics of Voclosporin in Adolescents With Lupus Nephritis
Phase 3 trial

Principal Investigator
Keisha Gibson, MD
keisha_gibson@med.unc.edu

Study Coordinators
Jasmine Durham
jrdurham@email.unc.edu

Research for Me: studies.unc.edu/21-3262
Clinical Trials.gov Link: https://clinicaltrials.gov/ct2/show/NCT05288855

More Information for Providers
Clinical Research Enrolling