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NCT01029587 · ClinicalTrials.gov registry record · Phase 2
Eculizumab to Enable Renal Transplantation in Patients With History of Catastrophic Antiphospholipid Antibody Syndrome
A Phase 2 study of End Stage Renal Disease and Antiphospholipid Antibody Syndrome, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 2
- Development phase
- 1
- Enrollment target
- 1
- Study location
NCT01029587 is a Phase 2 study of End Stage Renal Disease and Antiphospholipid Antibody Syndrome that has completed, run by Johns Hopkins University. The registered enrollment target is 1 participants, below the 833-participant average among 86 other End Stage Renal Disease trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01029587, a Phase 2 study of End Stage Renal Disease and Antiphospholipid Antibody Syndrome, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 1 participants
- Enrollment target
- 1
- Study location
Study Summary
Catastrophic Antiphospholipid Antibody Syndrome (CAPS) is a rare condition in which life-threatening blood clots form in multiple organs simultaneously and can lead to multi-organ system failure and death. The causes of CAPS are not entirely understood, but CAPS episodes are often triggered by stressful events such as infections, surgery, or trauma. For patients who survive an episode of CAPS, permanent kidney failure is not uncommon because the kidneys are the organ system most frequently affected in CAPS. Kidney transplantation is the treatment of choice for end-stage kidney disease, but patients with a history of CAPS are exceptionally high-risk kidney transplant recipients because the chance that surgery itself could trigger a life-threatening or transplant-threatening episode of CAPS is significant. As a result, patients with CAPS are not generally considered candidates for transplantation. Despite this, these patients have a severely decreased life-expectancy on dialysis and their long-term survival and quality of life would be greatly increased by a successful kidney transplant. In this trial, a drug called eculizumab will be tested for its ability to prevent CAPS after kidney transplantation in patients with a prior history of CAPS. Eculizumab is an inhibitor of the complement system, which is believed to be important in generating the inflammatory environment that leads to diffuse clotting of blood vessels in CAPS. The investigators hypothesize that by blocking the complement cascade using eculizumab, in conjunction with blocking the coagulation system, that kidney transplantation can be safely and successfully performed in patients with a history of CAPS.
Conditions Studied
Interventions
- DRUG Eculizumab
Study Locations (1)
Maryland
- Johns Hopkins University School of Medicine - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2009-11 |
| Est. Completion | 2010-05-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01029587
The ClinicalTrials.gov registry entry for NCT01029587 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 833-participant average among 86 other End Stage Renal Disease trials with a reported enrollment target (100% lower). The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with End Stage Renal Disease appearing as the primary indexed condition, and to 1 intervention - of which Eculizumab is the first listed.
NCT01029587 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT01029587 about?
NCT01029587 is a clinical study titled "Eculizumab to Enable Renal Transplantation in Patients With History of Catastrophic Antiphospholipid Antibody Syndrome". Catastrophic Antiphospholipid Antibody Syndrome (CAPS) is a rare condition in which life-threatening blood clots form in multiple organs simultaneously and can lead to multi-organ system failure and death. The causes of CAPS are not entirely understood, but CAPS episodes are often triggered by stres...
What is the current status of trial NCT01029587?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2009-11. Estimated completion is 2010-05-06.
What conditions does trial NCT01029587 study?
This clinical trial studies the following conditions: End Stage Renal Disease, Antiphospholipid Antibody Syndrome.
What interventions are being tested in trial NCT01029587?
The interventions under investigation include: Eculizumab (DRUG).
Who is sponsoring clinical trial NCT01029587?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01029587 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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