NCT01172418

Randomized Trial of 2 Antibody Induction Steroid Avoidance Protocols

Randomized Trial of 2 Antibody Induction Steroid Avoidance Protocols Accompanied by Maintenance Therapy With Prograf® and Myfortic®

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the present study is to determine which antibody induction regimen will result in a safer and more effective method to use with steroid avoidance in renal transplant recipients. Patients receiving either first cadaveric or non-HLA identical living donor kidney transplants will be preoperatively randomized into 2 groups.

Detailed description

Antibody Induction: Group I: Our standard steroid avoidance protocol, i.e., 3 daily doses of 1 mg/kg of Thymoglobulin®, the first to be infused at surgery, accompanied by 2 doses of anti-CD25 humanized monoclonal antibody, the first also to be given at surgery, and the second 2 weeks later. (controls) Group II: A new steroid avoidance protocol in which 1 dose of 1 mg/kg of Thymoglobulin® is to be infused at surgery followed by 1 dose of alemtuzumab (Campath-1H) at 0.3 mg/kg within 24 hours. No further antibody therapy will be used. In both groups, Prograf® maintenance therapy will be rapidly initiated (vide-infra) with a targeting dosage to 12 hour trough levels of 4 to 8 ng/ml. In Group I, maintenance dosing Myfortic® will be targeted to 720 mg twice daily. In Group II, maintenance doses of Myfortic® will be targeted to 360 mg twice daily. Steroids are to be given equivalently in both groups only during the first week postoperatively. The regimen consists of 500 mg/day of Solumedrol intravenously for 3 postoperative days followed by daily oral methylprednisolone or IV Solumedrol at 1 mg/kg per day, decreasing to 0.5 mg/kg per day during the remainder of the week primarily to avoid hypersensitivity reactions to the induction antibodies. No further steroid use is planned.

Conditions

• Transplant; Failure, Kidney

Interventions

Type	Name	Description
DRUG	Alemtuzumab	Alemtuzumab used as part of combined Induction.
DRUG	Daclizumab	Daclizumab used as part of combined induction.
DRUG	Thymoglobulin	Thymoglobulin used as part of combined induction.

Timeline

• Start date: 2006-02-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2010-07-29
• Last updated: 2023-09-28
• Results posted: 2014-08-20

Locations

1 site across 1 country: United States