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NCT00050713 · ClinicalTrials.gov registry record · Phase 2
Sirolimus Therapy for Idiopathic and Lupus Membranous Nephropathy
A Phase 2 study of Membranous Glomerulonephritis and Lupus Membranous Nepropathy, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT00050713 is a Phase 2 study of Membranous Glomerulonephritis and Lupus Membranous Nepropathy that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 12 participants. The trial reports 1 study location across 1 state.
The verdict
NCT00050713, a Phase 2 study of Membranous Glomerulonephritis and Lupus Membranous Nepropathy, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will evaluate the safety and effectiveness of a new immunosuppressive drug, sirolimus, in reducing the amount of protein in the urine in patients with membranous nephropathy. This condition involves damage to the walls of tiny blood vessel filters in the kidneys called glomeruli, which allows blood proteins to leak into the urine. Patients have low blood protein levels and high blood cholesterol. Some patients may have leg swelling, impaired kidney function, blood vessel and heart disease, and a risk of emboli (blood clots that travel to the lungs). Drugs currently used to treat membranous nephropathy vary in their effectiveness among patients and can cause severe side effects. The Food and Drug Administration has approved sirolimus for suppressing the immune system of patients who have had a kidney transplant to reduce the risk of organ rejection. The drug does not have certain side effects that have caused problems for patients treated with other immunosuppressants, such as: prednisone (weight gain, round face, diabetes, weak and fractured bones, and cataracts); cyclophosphamide (fertility problems, bladder injury and bladder cancer, and other cancers); chlorambucil (fertility problems, seizures, acute leukemia, and other cancers); and cyclosporine (kidney toxicity, increased facial hair, and seizures). Patients 13 years of age or older with idiopathic membranous nephropathy or lupus membranous nephropathy may be eligible for this study. Candidates must have completed at least one month of treatment with a stable dose of angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs). They will be screened with a medical history, physical examination, blood tests, skin test for exposure to tuberculosis, and an examination for infection, cancers, and other conditions that can cause membranous nephropathy. Participants will take sirolimus once a day for 1 year, except for the first day of treatment, when they will take three dose
Conditions Studied
Interventions
- DRUG Sirolimus
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2002-12-17 |
| Est. Completion | 2007-08-27 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00050713
The ClinicalTrials.gov registry entry for NCT00050713 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 12 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 2 conditions, with Membranous Glomerulonephritis appearing as the primary indexed condition, and to 1 intervention - of which Sirolimus is the first listed.
NCT00050713 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00050713 about?
NCT00050713 is a clinical study titled "Sirolimus Therapy for Idiopathic and Lupus Membranous Nephropathy". This study will evaluate the safety and effectiveness of a new immunosuppressive drug, sirolimus, in reducing the amount of protein in the urine in patients with membranous nephropathy. This condition involves damage to the walls of tiny blood vessel filters in the kidneys called glomeruli, which al...
What is the current status of trial NCT00050713?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2002-12-17. Estimated completion is 2007-08-27.
What conditions does trial NCT00050713 study?
This clinical trial studies the following conditions: Membranous Glomerulonephritis, Lupus Membranous Nepropathy.
What interventions are being tested in trial NCT00050713?
The interventions under investigation include: Sirolimus (DRUG).
Who is sponsoring clinical trial NCT00050713?
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 NCT00050713 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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