Clinical/Treatment Trials
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?
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.
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.
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
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
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
Sara Kelley, MPH
sara_kelley@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
Veronica Joseph
veronica_joseph@med.unc.edu
Clinical Trials.gov Link – Adults: https://clinicaltrials.gov/study/NCT05997875
CONFIDENCE: A Study to Learn How Well the Treatment Combination of Finerenone and Empagliflozin Works in Participants with Kidney Disease and Diabetes
Principal Investigator
Amy Mottl, MD
amy_mottl@med.unc.edu
Study Coordinator
Sara Kelley, MPH
sara_kelley@med.unc.edu
Research for Me: studies.unc.edu/22-1479
Clinical Trials.gov Link: https://clinicaltrials.gov/ct2/show/NCT05254002
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
ASSIST: Randomized, Double-blind, Placebo-controlled, Crossover Study of Atrasentan in Subjects With IgA Nephropathy (ASSIST)
Principal Investigator
Amy Mottl, MD
amy_mottl@med.unc.edu
Study Coordinators
Anne Froment, MSW
anne_froment@med.unc.edu
Research for Me: studies.unc.edu/23-1061
Clinical Trials.gov Link: https://classic.clinicaltrials.gov/ct2/show/NCT05834738
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
Safety and Efficacy of Ravulizumab in Participants with Lupus Nephritis
Phase 2 trial
Principal Investigator
Amy Mottl, MD
amy_mottl@med.unc.edu
Study Coordinators
Anne Froment, MSW
anne_froment@med.unc.edu
Research for Me: studies.unc.edu/20-3399
Clinical Trials.gov Link: https://clinicaltrials.gov/ct2/show/NCT04564339
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
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
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