Dosing Regimen of Eculizumab Added to Conventional Treatment in Positive

Status Completed

Clinical Trial Summary

A strongly positive crossmatch has long been considered an absolute contraindication to kidney transplantation and most patients with anti-human leukocyte antigen (HLA) antibody never were able to receive a kidney transplant. Over the past decade, significant progress has been made in overcoming early antibody-mediated renal allograft injury. Our group has performed more than 200 such transplants providing the possibility of transplant to previously untransplantable patients. Despite our best efforts, transplantation in these patients is still complicated by a high rate of acute humoral rejection (AHR).

Patients included in this study will be those who have demonstrable anti-HLA antibody specific for their living donor. It is our hypothesis that blockade of terminal complement activation at the time of transplant in combination with our current protocols will reduce the incidence of AHR in patients with anti-donor HLA antibody.

Clinical Trial Description

The eculizumab dosing regimen was modified from that used in the treatment of paroxysmal nocturnal hemoglobinuria and consisted of 1200 mg immediately prior to transplantation, 600 mg on postoperative day 1, and 600 mg weekly thereafter for 4 weeks. At week 4, assessment of DSA levels was performed. Eculizumab was discontinued in patients whose DSA had significantly decreased (B flow crossmatch channel shift<200). In patients with persistently high DSA and thus believed to have continued high risk for AMR, eculizumab treatment continued (1200 mg week 5, and then every 2 weeks). Another DSA assessment was performed at week 9 and eculizumab was discontinued if the B flow crossmatch channel shift was <200.

The eculizumab group were compared to a historical control group consisting of consecutive transplants between 1/1/2005 and 1/10/2017 who met the inclusion criteria. The historical control group had been treated with a similar plasma exchange based protocol without eculizumab. ;

Study Design

Related Conditions & MeSH terms

Kidney Transplant

Clinical Trial Details

NCT number	NCT00670774
Study type	Interventional
Source	Mayo Clinic
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	March 2008
Completion date	August 2017

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04087720` - Study of Pegloticase in Participants With Uncontrolled Gout Who Have Had a Kidney Transplant	Phase 4
Completed	`NCT03749356` - Study to Evaluate the Efficacy and Safety of Once-Daily Tacrolimus in Kidney Transplant Recipients	Phase 4
Withdrawn	`NCT05811468` - Study Correlation Between Blood, Tissue Gene Expression, Donor Derived Cell Free DNA and Histopathology in Kidney Transplant Recipients
Completed	`NCT03527238` - Optimizing Immunosuppression Drug Dosing Via Phenotypic Precision Medicine	Phase 2
Completed	`NCT00498576` - Melatonin and Adiponectin in Hypertensive Kidney Transplant	N/A
Completed	`NCT00642655` - Rituximab and Intravenous Immunoglobulin (IVIG) for Desensitization in Renal Transplantation	Phase 1/Phase 2
Completed	`NCT00374400` - The Paired Donation Consortium Paired Donation Program	N/A
Completed	`NCT01710033` - A Study Of CP-690,550 In Stable Kidney Transplant Patients	Phase 1
Completed	`NCT00205257` - Prediction of Acute Rejection in Renal Transplant	Phase 1
Completed	`NCT02711826` - Treg Therapy in Subclinical Inflammation in Kidney Transplantation	Phase 1/Phase 2
Withdrawn	`NCT03978494` - Study to Compare Pharmacokinetics of Tacrolimus Prolonged-release (PR) Capsules and Advagraf® PR Capsules in Stable Kidney Transplant Patients.	Phase 1
Completed	`NCT03837522` - Trial to Define the Benefits and Harms of Deceased Donor Kidney Procurement Biopsies	N/A
Not yet recruiting	`NCT06025240` - Expanding the Scope of Post-transplant HLA-specific Antibody Detection and Monitoring in Renal Transplant Recipients
Completed	`NCT05029310` - Effects of Patiromer on Pharmacokinetics of Immunosuppresive Drugs in Renal Transplant Recipients	Phase 4
Completed	`NCT03644485` - Clinical Outcome of Delayed or Standard Prograf Together With Induction Therapy Followed by Conversion to Advagraf in Donation After Cardiac (or Circulatory) Death (DCD) Kidney Transplant Recipients	Phase 4
Active, not recruiting	`NCT02409901` - Effects of Personalized Physical Rehabilitation in Kidney Transplant Recipients	N/A
Completed	`NCT01047410` - ACtive Care After Transplantation, the ACT Study	N/A
Completed	`NCT00940940` - Safety and Immunogenicity of Zostavax Vaccine in Patients Undergoing Living Donor Kidney Transplantation	Phase 4
Completed	`NCT00270712` - A Study of Factors That Affect Long-Term Kidney Transplant Function
Completed	`NCT00217126` - The Study of Long-term Deterioration of Kidney Transplants.	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Dosing Regimen of Eculizumab Added to Conventional Treatment in Positive Cross Match Living Donor Kidney Transplant

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms