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NCT00001212 · ClinicalTrials.gov registry record · Phase 2
Drug Therapy in Lupus Nephropathy
A Phase 2 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 2
- Development phase
- 45
- Enrollment target
NCT00001212 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 45 participants.
The verdict
NCT00001212, 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
- 45 participants
- Enrollment target
Study Summary
Studies have shown that up to 26% of patients with systemic lupus erythematoses nephritis may suffer from membranous lupus nephropathy. The disease is characterized by high levels of protein in the urine and may eventually lead to kidney failure. This study will evaluate the effectiveness and toxic effects of immunosuppressive drug therapy in patients with membranous lupus nephropathy over a 12 month period. The major goal of this therapy is to decrease protein losses and ultimately prevent kidney failure. Patients enrolled in the study will undergo a routine history and physical examination. In addition, several diagnostic tests will be conducted including; chest x-ray ECG, blood and urine laboratory tests. Patients will be divided and grouped according to the severity of their disease as shown by kidney function. Each group will then randomly be subcategorized by different treatment plans. Each treatment plan will made up of immunosuppressive medications including prednisone, cyclophosphamide, cyclosporin A, and combinations of these drugs. Patients will receive the medications as directed by the study. The study will last 12 months and require patients to be admitted for two to five days before the study begins and once the study is completed. Patients will be followed as outpatients throughout the 12 month study.
Interventions
- DRUG prednisone
- DRUG cyclophosphamide
- DRUG cyclosporin A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 1986-11 |
| Est. Completion | 2004-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001212
The ClinicalTrials.gov registry entry for NCT00001212 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 45 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 3 interventions - of which prednisone is the first listed.
NCT00001212 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00001212 about?
NCT00001212 is a clinical study titled "Drug Therapy in Lupus Nephropathy". Studies have shown that up to 26% of patients with systemic lupus erythematoses nephritis may suffer from membranous lupus nephropathy. The disease is characterized by high levels of protein in the urine and may eventually lead to kidney failure. This study will evaluate the effectiveness and toxic...
What is the current status of trial NCT00001212?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 1986-11. Estimated completion is 2004-09.
What interventions are being tested in trial NCT00001212?
The interventions under investigation include: prednisone (DRUG), cyclophosphamide (DRUG), cyclosporin A (DRUG).
Who is sponsoring clinical trial NCT00001212?
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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