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NCT00065611 · ClinicalTrials.gov registry record · Phase 3
Steroid Treatment for Kidney Disease
A Phase 3 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 3
- Development phase
- 8
- Enrollment target
NCT00065611 is a Phase 3 study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 8 participants.
The verdict
NCT00065611, a Phase 3 study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 8 participants
- Enrollment target
Study 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.
Interventions
- DRUG Oral dexamethasone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2003-07 |
| Est. Completion | 2010-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00065611
The ClinicalTrials.gov registry entry for NCT00065611 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. 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 0 conditions, and to 1 intervention - of which Oral dexamethasone is the first listed.
NCT00065611 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00065611 about?
NCT00065611 is a clinical study titled "Steroid Treatment for Kidney Disease". 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 stud...
What is the current status of trial NCT00065611?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 8 participants. The study started on 2003-07. Estimated completion is 2010-08.
What interventions are being tested in trial NCT00065611?
The interventions under investigation include: Oral dexamethasone (DRUG).
Who is sponsoring clinical trial NCT00065611?
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.
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