At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 8 enrolled

Drug / intervention

Oral dexamethasonedrug

Likely dose

Stage I: Dexamethasone 25 mg/m² (2 doses every 2 weeks or 4 doses every 4 weeks over 48 weeks). Stage II: Dexamethasone 50 mg/m² (2 daily doses every 12 weeks) followed by 25 mg/m² (2 daily doses every 2 weeks over 36 weeks), or alternative Stage II regimen.AI-extracted

Key inclusion· 7

✓Adults and children greater than 2.0 years of age are eligible.
✓Biopsy-proven MCD and its variants (IgM nephropathy, mesangial hypertrophy) OR biopsy-proven idiopathic or collapsing FSGS.
✓Nephrotic-range proteinuria: ≥3.5 g/1.73m²/day (adults) or ≥50 mg/kg/day (children <40 kg) while on maximally tolerated angiotensin antagonist for ≥4 weeks.
✓Estimated GFR ≥40 mL/min/1.73m² at study entry.

Key exclusion· 7

✕Type 1 diabetes mellitus. Type 2 diabetes allowed only if HbA1c <7.5%, no proliferative retinopathy, and renal biopsy within 6 months shows no diabetic nephropathy.
✕Poorly controlled hypertension: >25% of values >125/75 mmHg.
✕Evidence of active hepatitis B, hepatitis C, HIV-1 infection, or untreated mycobacterial infection.
✕Immunosuppressive medication other than glucocorticoids (including topical agents excluded) discontinued less than 8 weeks prior to study entry.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00065611

NCT00065611Phase 3Completed

Compare CT.gov

Pulse Dexamethasone Over 48 Weeks for Podocyte Disease

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·interventional·Posted Jul 29, 2003·Updated Oct 28, 2011

In Brief

A Phase 3 clinical trial evaluating Oral dexamethasone for Nephrosis and Focal Lipoid Glomerulosclerosis. Completed, enrolled 8 participants across 1 site.

Detailed Summary

Focal segmental glomerulosclerosis (FSGS) and minimal change disease are kidney diseases that are associated with increased excretion of protein in the urine. Approximately half of FSGS patients will lose kidney function within 8 years of diagnosis and will require dialysis. The purpose of this study is to determine whether intermittent oral steroid therapy can cause sustained remission of FSGS and MCD. Approximately 70 participants, including adults and children older than age 2, will be enrolled in this study. They will receive 48 doses of oral dexamethasone over a period of 48 weeks. One group will take two daily doses every 2 weeks; the other group will take four daily doses every 4 weeks. Doctors will monitor participants before, during, and after the steroid treatment with extensive exams and testing. At the completion of the study, researchers will evaluate the safety and efficacy of the drug treatment.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsNephrosis, Focal Lipoid Glomerulosclerosis

CountriesUnited States

Collaborators--

Timeline

Phase 3CompletedFinished

2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartJul 2003

First PostedJul 2003

Primary CompletionAug 2010

TodayJul 2026

First PostedJul 29, 2003

Enrollment StartJul 1, 2003

Primary CompletionAug 1, 2010

TodayJul 2, 2026

Enrollment to primary: 7.1 yearsPosted 22.9 years ago

Interventions

Oral dexamethasonedrug

Stage I: Dexamethasone 25 mg/m2, 2 doses every 2 weeks over 48 weeks or dexamethasone 25 mg/m2, 4 doses every 4 weeks over 48 weeks. Stage II: 1.) Dexamethasone 50 mg/m2, 2 daily doses every 12 weeks, followed by 25 mg/m2, 2 daily doses every 2 weeks over 36 weeks, or 2.) Dexamethasone 50 mg/m2, 4 daily doses every 4 weeks over 12 weeks, followed by 25 mg/m2, 4 daily doses every 4 weeks over 36 weeks. over 36 weeks.