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NCT01129284 · ClinicalTrials.gov registry record · Phase 4
Treatment of Resistant Nephrotic Syndrome With ACTH Gel (ACTHAR)
A Phase 4 study, sponsored by Columbia University.
- Completed
- Registry status
- Phase 4
- Development phase
- 15
- Enrollment target
NCT01129284 is a Phase 4 study that has completed, run by Columbia University. The registered enrollment target is 15 participants.
The verdict
NCT01129284, a Phase 4 study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 15 participants
- Enrollment target
Study Summary
This study will examine the safety and effectiveness of ACTHAR Gel, when used to treat 15 patients diagnosed with "treatment resistant nephrotic syndrome." Nephrotic syndrome is a group of symptoms that includes low levels of protein in the blood, swelling of tissue (edema), especially around the eyes, feet and hands; and high plasma levels of cholesterol. It is caused by a variety of diseases and underlying disorders that damage the kidneys, resulting in excessive excretion of protein in the urine. These diseases damage the glomeruli, which are small blood vessels that filter wastes and excess water from the blood and pass them into the bladder as urine. As a result of protein loss in the urine, the blood is deficient in protein. Normal amounts of blood protein are needed to help regulate fluid throughout the body. Protein in the blood normally draws water from the tissues and into the bloodstream. When blood protein levels are low, the normal movement of water is reversed, and fluid is drawn from the blood and accumulates in the tissues. This excess tissue fluid causes the swelling and puffiness (edema) that is a symptom of nephrotic syndrome. Nephrotic syndrome is described as "treatment resistant" when a patient fails to achieve a sustained partial or complete remission after treatment with at least two first line therapies. The goal of this study is to determine whether injections of ACTHAR Gel (an FDA approved treatment for nephrotic syndrome) over a six month period will lead to a correction of treatment resistant nephrotic syndrome in these patients.
Interventions
- DRUG ACTHAR gel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2009-12 |
| Est. Completion | 2011-09 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01129284
The ClinicalTrials.gov registry entry for NCT01129284 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ACTHAR gel is the first listed.
NCT01129284 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01129284 about?
NCT01129284 is a clinical study titled "Treatment of Resistant Nephrotic Syndrome With ACTH Gel (ACTHAR)". This study will examine the safety and effectiveness of ACTHAR Gel, when used to treat 15 patients diagnosed with "treatment resistant nephrotic syndrome." Nephrotic syndrome is a group of symptoms that includes low levels of protein in the blood, swelling of tissue (edema), especially around the e...
What is the current status of trial NCT01129284?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 15 participants. The study started on 2009-12. Estimated completion is 2011-09.
What interventions are being tested in trial NCT01129284?
The interventions under investigation include: ACTHAR gel (DRUG).
Who is sponsoring clinical trial NCT01129284?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
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