Clinical Trial: Eculizumab to Enable Renal Transplantation in Patients With History of Catastrophic Antiphospholipid Antibody Syndrome
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Phase 2 Study of the Use of Eculizumab to Prevent Thrombosis After Renal Transplantation in Patients With a History of Catastrophic Antiphospholipid Antibody Syndrome (CAP
Brief 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.
Detailed Summary:
Sponsor: Johns Hopkins University
Current Primary Outcome: Prevention of CAPS after kidney transplant [ Time Frame: 1 year ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Kidney transplant graft survival [ Time Frame: 1 year, 5 years ]
- Patient survival [ Time Frame: 1 year, 5 years ]
Original Secondary Outcome: Same as current
Information By: Johns Hopkins University
Dates:
Date Received: December 9, 2009
Date Started: November 2009
Date Completion: July 2020
Last Updated: March 30, 2017
Last Verified: March 2017
