Focal Segmental Glomerulosclerosis Clinical Trial
Official title:
A Phase I, Multicentre, Open-label, Dose-escalating Study of Single Doses of GC1008 in Patients With Treatment Resistant Idiopathic Focal Segmental Glomerulosclerosis (FSGS)
This study will investigate whether GC1008, an antibody which neutralizes TGF-beta, is safe in treating patients with the disease called focal segmental glomerulosclerosis (FSGS). The highest dose without excessive side effects will be investigated. Tests will determine how long GC1008 is in the body and how it is excreted.
Patients in each cohort will receive a single dose of GC1008 infusion at 1, 2, 4 or 0.3 mg/kg body weight. The higher dose cohort will not start until the first 28 days safety data for the lower dose cohort have been reviewed by the independent Data Monitoring Committee (DMC). Cohort C and D will run concurrently with patients randomised to receive either a 4 or 0.3 mg/kg body weight dose, respectively. After receiving the infusion of GC1008 on Day 0, patients will be monitored for the 24 hours following the infusion. Patients will return periodically over the following 112 days for safety evaluations and clinical outcome assessments. Blood samples will be collected to evaluate the pharmacokinetics of single dose administration of GC1008 as well as for evaluation of markers of clinical efficacy ;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02585804 -
Treating to Reduce Albuminuria and Normalize Hemodynamic Function in Focal ScLerosis With dApagliflozin Trial Effects
|
Phase 4 | |
| Terminated |
NCT01129557 -
Aldosterone Breakthrough During Diovan, Tekturna, and Combination Therapy in Patients With Proteinuric Kidney Disease
|
Phase 4 | |
| Not yet recruiting |
NCT00956059 -
Therapeutic Effect of Low-dose Prednisone Combined With MMF and FK506 in Focal Segmental Glomerulosclerosis
|
N/A | |
| Recruiting |
NCT05583942 -
A Pilot Trial of taVNS for SRNS in Children (kidNEY-VNS)
|
N/A | |
| Recruiting |
NCT05588063 -
taVNS for FRNS in Children
|
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 |
NCT03536754 -
A Study of CCX140-B in Subjects With FSGS
|
Phase 2 | |
| Recruiting |
NCT03929887 -
KOrea Renal Biobank NEtwoRk System TOward NExt-generation Analysis
|