Clinical Trials Logo
  1. Home
  2. Alport Syndrome
  3. NCT05267262

Study to Evaluate R3R01 in Patients With Alport Syndrome and Patients With Focal Segmental Glomerulosclerosis

Focal Segmental Glomerulosclerosis Clinical Trial

Official title:
A Phase II, Multi-center, Open-Label Study to Assess Safety, Tolerability, Efficacy and Pharmacokinetics of R3R01 in AS Patients With Uncontrolled Proteinuria on ACE/ARB Inhibition and in Patients With Primary Steroid-Resistant FSGC

Clinical Trial Summary

This is a Phase 2, Multi-center, Open-Label Study to Assess Safety, Tolerability, Efficacy and Pharmacokinetics of R3R01 in Alport Syndrome Patients with Uncontrolled Proteinuria on ACE/ARB Inhibition and in Patients with Primary Steroid-Resistant Focal Segmental Glomerulosclerosis

Clinical Trial Description

R3R01 is investigational small molecule designed to decrease fat levels in certain cells in the kidney and therefore may improve kidney function and reduce damage in the kidney. This is a single arm open-label study enrolling patients in three cohorts. Cohort 1 will include 5 adult (≥18 y/o) patients from Cohorts 2 and 3 (including at least one patient from Cohort 2 and at least one patient from Cohort 3). Cohort 2 will include approximately 20 male and female patients from 12 years and older with X-linked Alport Syndrome (AS), and male and female patients with autosomal inherited AS. Cohort 3 will include approximately 30 male and female patients from age 12 to 75 years with a biopsy proven diagnosis who present with primary steroid-resistant focal segmental glomerulosclerosis (FSGS) with proteinuria. All eligible patients will be enrolled to receive R3R01 over a treatment period of 12 weeks with a primary efficacy outcome as the percentage change in proteinuria from baseline to the end of treatment (Day 84) in each cohort as a whole ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05267262
Study type Interventional
Source River 3 Renal Corp.
Contact Kathie Gabriel, RN, MFT
Phone 610-937-1932
Email kgabriel@narrowrivermgmt.com
Status Recruiting
Phase Phase 2
Start date June 15, 2022
Completion date June 2, 2025
View Details
See also
  Status Clinical Trial Phase
Completed NCT02585804 - Treating to Reduce Albuminuria and Normalize Hemodynamic Function in Focal ScLerosis With dApagliflozin Trial Effects Phase 4
Not yet recruiting NCT00956059 - Therapeutic Effect of Low-dose Prednisone Combined With MMF and FK506 in Focal Segmental Glomerulosclerosis N/A
Terminated NCT01129557 - Aldosterone Breakthrough During Diovan, Tekturna, and Combination Therapy in Patients With Proteinuric Kidney Disease Phase 4
Recruiting NCT05588063 - taVNS for FRNS in Children N/A
Recruiting NCT05583942 - A Pilot Trial of taVNS for SRNS in Children (kidNEY-VNS) N/A
Completed NCT04369183 - Rituximab for Refractory or Relapsed Focal Segmental Glomerulosclerosis or Minimal Change Disease
Recruiting NCT02896270 - Valproic Acid for Idiopathic Nephrotic Syndrome Phase 2/Phase 3
Completed NCT01113385 - Oral Galactose in Children With Steroid Resistant Nephrotic Syndrome N/A
Terminated NCT00883636 - Cardiomyopathy in Steroid-resistant Nephrotic Syndrome: Impact of Focal Segmental Glomerulosclerosis N/A
Completed NCT04009668 - Tumor Necrosis Factor Inhibition in Focal Segmental Glomerulosclerosis and Treatment Resistant Minimal Change Disease Phase 2
Terminated NCT03703908 - A Study of CCX140-B in Subjects With Primary FSGS and Nephrotic Syndrome Phase 2
Completed NCT03649152 - Safety and Effectiveness of Propagermanium in Focal Segmental Glomerulosclerosis Participants Receiving Irbesartan Phase 2
Recruiting NCT06065852 - National Registry of Rare Kidney Diseases
Completed NCT00255398 - Kidney Disease Biomarkers
Terminated NCT05441826 - Efficacy and Safety of VB119 in Subjects With Minimal Change Disease (MCD) and Focal Segmental Glomerulosclerosis (FSGS) Phase 2
Recruiting NCT02235857 - Post Approval Study of Liposorber LA-15 System for the Treatment of Focal Segmental Glomerulosclerosis in Children N/A
Recruiting NCT05942625 - A First in Human Study to Evaluate Safety, Tolerability, Pharmacology of HS-10390 in Healthy Subjects Phase 1
Recruiting NCT02382874 - Allogenic AD-MSC Transplantation in Idiopathic Nephrotic Syndrome (Focal Segmental Glomerulosclerosis) Phase 1
Completed NCT00464321 - Safety Study of GC1008 in Patients With Focal Segmental Glomerulosclerosis (FSGS) of Single Doses of GC1008 in Patients With Treatment Resistant Idiopathic FSGS Phase 1
Completed NCT03536754 - A Study of CCX140-B in Subjects With FSGS Phase 2