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NCT00004990 · ClinicalTrials.gov registry record · Phase 2
Once-A-Month Steroid Treatment for Patients With Focal Segmental Glomerulosclerosis
A Phase 2 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT00004990 is a Phase 2 study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 20 participants.
The verdict
NCT00004990, a Phase 2 study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
This study will test the safety and effectiveness of a monthly dosing regimen of dexamethasone-a strong steroid medication-to treat patients with focal segmental glomerulosclerosis (FSGS). Patients with this disease have kidney fibrosis (scarring) and proteinuria (excessive excretion of protein in the urine) that, in about half of the patients eventually requires kidney dialysis or transplant. Currently, the most effective treatment for FSGS is high-dose steroids (prednisone) taken daily for 4 to 6 months. However, only about 30 percent of patients respond to this treatment, and it causes serious side effects in many patients. Other drugs, such as cyclosporin and cyclophosphamide, improve proteinuria in even fewer patients (about 10 percent) and also have serious side effects. This study will explore whether a monthly pulse dose of steroids will achieve disease remission with less toxicity. Adults and children with FSGS who: 1) have not received steroid treatment, or 2) could not tolerate daily steroid treatment, or 3) relapsed after conventional steroid treatment may be eligible for this study. Those enrolled will take dexamethasone by mouth for 4 days every 4 weeks for a total of 8 months. Patients will undergo various tests before treatment starts (baseline), during the course of treatment, and in follow-up visits to evaluate the effects of treatment as follows: 1. Review of kidney biopsy, medical evaluation, measurement of total daily urine protein excretion and kidney function, psychiatric testing for depression or other mood disorder 2. Measurements of blood pressure, blood chemistries and urine protein excretion - monthly during treatment 3. Questionnaire about the effects of treatment, if any, on mood and feelings - monthly during treatment 4. Photographs of the face and body (in underwear or shorts and tank top) to evaluate body fat distribution- baseline and 8 months 5. Eye examinations for cataracts and glaucoma - baseline and 8 months 6. Bone density s
Interventions
- DRUG Dexamethasone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2000-03 |
| Est. Completion | 2004-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00004990
The ClinicalTrials.gov registry entry for NCT00004990 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 20 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 Dexamethasone is the first listed.
NCT00004990 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00004990 about?
NCT00004990 is a clinical study titled "Once-A-Month Steroid Treatment for Patients With Focal Segmental Glomerulosclerosis". This study will test the safety and effectiveness of a monthly dosing regimen of dexamethasone-a strong steroid medication-to treat patients with focal segmental glomerulosclerosis (FSGS). Patients with this disease have kidney fibrosis (scarring) and proteinuria (excessive excretion of protein in t...
What is the current status of trial NCT00004990?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2000-03. Estimated completion is 2004-12.
What interventions are being tested in trial NCT00004990?
The interventions under investigation include: Dexamethasone (DRUG).
Who is sponsoring clinical trial NCT00004990?
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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