Ignite Creation Date:
2024-05-05 @ 10:04 PM
Last Modification Date:
2024-10-26 @ 10:13 AM
Study NCT ID:
NCT01029587
Status:
COMPLETED
Last Update Posted:
2020-10-26
First Post:
2009-12-09
Brief Title:
Eculizumab to Enable Renal Transplantation in Patients With History of Catastrophic Antiphospholipid Antibody Syndrome
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Eculizumab to Enable Renal Transplantation in Patients With History of Antiphospholipid Antibody Syndrome or Catastrophic Antiphospholipid Antibody Syndrome
Status:
COMPLETED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None