Eculizumab to Enable Renal Transplantation in Patients With History of Catastrophic Antiphospholipid Antibody Syndrome
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Antiphospholipid Antibody Syndrome End Stage Renal Disease |
Drug: Eculizumab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| 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 (CAPS) |
- Prevention of CAPS after kidney transplant [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Kidney transplant graft survival [ Time Frame: 1 year, 5 years ] [ Designated as safety issue: No ]
- Patient survival [ Time Frame: 1 year, 5 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 10 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | August 2015 |
| Estimated Primary Completion Date: | August 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Eculizumab
Patients will receive eculizumab in conjunction with systemic anticoagulation before and after kidney transplant operation
|
Drug: Eculizumab
Eculizumab will be administered by intravenous infusion. Eculizumab will be administered at a dose of 1200mg by intravenous (IV) infusion on the day of or on the day prior to kidney transplantation, and at a dose of 900mg IV on post-operative day 1. Subsequently, the post-operative dosing regimen would be comprised of an induction phase of weekly doses of 900mg IV per dose followed by a maintenance phase of every other week dosing of 1200mg IV per dose. The weekly induction dosing regimen would begin on postoperative day 8, and would continue for three doses (specifically, doses of 900mg IV would be given on postoperative days 8, 15, and 22). The maintenance phase of dosing would begin with a dose of 1200mg on postoperative day 29, and would continue for a total of 5 doses (specifically, doses of 1200mg IV would be given on postoperative days 29, 43, 47, 72, and 85). In most cases, eculizumab would be discontinued after the 5th maintenance dose.
Other Name: Soliris
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 18 years or older
- History of Catastrophic Antiphospholipid Antibody Syndrome (CAPS)
- End-stage renal disease
Exclusion Criteria:
- Any contraindications to transplantation other than CAPS
- Pregnant women
- Women who intend to become pregnant over the study period
- Ongoing or untreated meningococcal infections
- History of serious adverse reaction to eculizumanb
Contacts and Locations| Contact: Bonnie E Lonze, MD, PhD | 410-955-7120 | bel@jhmi.edu |
| Contact: Cinda Grisbach | 410-614-8297 | cgrisba1@jhmi.edu |
| United States, Maryland | |
| Johns Hopkins Medical Institutions | Recruiting |
| Baltimore, Maryland, United States, 21205 | |
| Principal Investigator: Robert A Montgomery, MD, DPhil | |
More Information
No publications provided
| Responsible Party: | Robert A. Montgomery MD DPhil, Director, Comprehensive Transplant Center, Johns Hopkins Hospital, The Johns Hopkins University School of Medicine, Dept of Surgery, Division of Transplantation |
| ClinicalTrials.gov Identifier: | NCT01029587 History of Changes |
| Other Study ID Numbers: | NA_00032637 |
| Study First Received: | December 9, 2009 |
| Last Updated: | August 16, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Johns Hopkins University:
|
CAPS Kidney transplant Renal transplant Catastrophic Antiphospholipid Antibody Syndrome |
Additional relevant MeSH terms:
|
Antiphospholipid Syndrome Kidney Diseases Kidney Failure, Chronic Urologic Diseases Renal Insufficiency, Chronic Renal Insufficiency Autoimmune Diseases |
Immune System Diseases Antibodies Antibodies, Antiphospholipid Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013