Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00007475 · ClinicalTrials.gov registry record · Phase 1
Permeability Factor in Focal Segmental Glomerulosclerosis
A Phase 1 study of Focal Segmental Glomerulosclerosis, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT00007475 is a Phase 1 study of Focal Segmental Glomerulosclerosis that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 15 participants, below the 236-participant average among 19 other Focal Segmental Glomerulosclerosis trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00007475, a Phase 1 study of Focal Segmental Glomerulosclerosis, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
Focal segmental glomerulosclerosis (FSGS) is a renal syndrome characterized by proteinuria (usually nephrotic range), limited response to conventional therapy, and a poor renal prognosis, with progression to end stage renal failure in at least 50% of patients. As a syndrome, FSGS likely has many specific etiologies, only a few of which are well-defined. Recently, it has been suggested that some idiopathic FSGS patients have elevated circulating levels of a protein that induces glomerular permeability in vitro and in vivo. While there has been no consistent term for this factor, it will be termed here FSGS permeability factor (FPF). The purposes of the present study are five fold: 1. To identify a population of FSGS patients with elevated FPF levels 2. To examine RNA expression profiles of peripheral blood mononuclear cells (PBMC) in FSGS patients with elevated FPF levels 3. To define the kinetics of FPF disappearance and reappearance in FSGS patients receiving immunomodulatory therapy and in the case of patients with recurrent FSGS following renal transplant, those receiving plasma exchange 4. To identify immunosuppressive agents which are successful in inducing sustained reduction in FPF levels 5. To determine in patients with FSGS who are awaiting renal transplant, whether sustained reduction in FPF levels is associated with reduced risk of recurrent FSGS. Patient participation is divided into an evaluation phase, in which FPF levels, RNA expression profiles, and patient eligibility for participation in treatment protocols are determined, and a treatment phase in which specific immunomodulatory therapy is introduced in an open label fashion. We propose to define carefully the relationship between elevated FPF and remission of proteinuria in patients with FSGS in native kidneys, following treatment with standard therapies (daily prednisone, cyclophosphamide) and experimental therapies (pulse dexamethasone, pirfenidone). In patients with recurrent FSGS in renal a
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- PROCEDURE Plasma exchange
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2000-12 |
| Est. Completion | 2014-06 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00007475
The ClinicalTrials.gov registry entry for NCT00007475 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 236-participant average among 19 other Focal Segmental Glomerulosclerosis trials with a reported enrollment target (94% lower). The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Focal Segmental Glomerulosclerosis appearing as the primary indexed condition, and to 2 interventions - of which Cyclophosphamide is the first listed.
NCT00007475 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00007475 about?
NCT00007475 is a clinical study titled "Permeability Factor in Focal Segmental Glomerulosclerosis". Focal segmental glomerulosclerosis (FSGS) is a renal syndrome characterized by proteinuria (usually nephrotic range), limited response to conventional therapy, and a poor renal prognosis, with progression to end stage renal failure in at least 50% of patients. As a syndrome, FSGS likely has many spe...
What is the current status of trial NCT00007475?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2000-12. Estimated completion is 2014-06.
What conditions does trial NCT00007475 study?
This clinical trial studies the following conditions: Focal Segmental Glomerulosclerosis.
What interventions are being tested in trial NCT00007475?
The interventions under investigation include: Cyclophosphamide (DRUG), Plasma exchange (PROCEDURE).
Who is sponsoring clinical trial NCT00007475?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00007475 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Focal Segmental Glomerulosclerosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
AMPK-activation by Metformin in FSGS: AMP-FSGS
RECRUITING · Phase 1
-
Recurrence Post-transplant Observational Study in Focal Segmental Glomerulosclerosis and Minimal Change Disease
RECRUITING
-
A Study of Praliciguat in Participants With Focal Segmental Glomerulosclerosis (FSGS)
RECRUITING · Phase 2
-
Study of Sparsentan Treatment in Pediatrics With Proteinuric Glomerular Diseases
RECRUITING · Phase 2
-
A Study to Find Out if BI 764198 Helps Adults and Adolescents With a Kidney Condition Called Focal Segmental Glomerulosclerosis (FSGS)
RECRUITING · Phase 3
-
Post Approval Study for Treatment of Drug-resistant Adult and Pediatric Primary FSGS Using the LIPOSORBER® LA-15 System
RECRUITING · NA
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.