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Antibody and Delayed Cyclosporine Versus Initial Cyclosporine Alone in Patients Receiving Kidney Transplants

NCT00007787 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2013-01-23

No results posted yet for this study

Summary

The purpose of this study is to see if kidney function can be improved during transplants by giving the drug Thymoglobulin with delayed cyclosporine treatment instead of initial cyclosporine treatment.

There have been improvements for patients receiving kidney transplants, yet acute rejection is still a problem. This can lead to kidney failure over time. Patients whose graft fails to function properly in the first week after transplant do not do as well after 5 years as compared to patients without early problems. This study will see if Thymoglobulin, a drug that suppresses the immune system, will improve early graft function.

Conditions

  • Kidney Transplantation
  • Chronic Allograft Nephropathy

Interventions

BIOLOGICAL

Cyclosporine

BIOLOGICAL

Anti-human thymocyte globulin (rabbit)

Anti-human thymocyte globulin (rabbit) will be given at a dose of 1.5 mg/kg while undergoing transplantation. Second and subsequent doses of Thymoglobulin® will be administered if, at 24 hours post-anastomosis, the serum creatinine has not decreased by at least 20% from the pre-transplant level. Additional Anti-human thymocyte globulin (rabbit) will be given at a dose of 1.5mg/kg daily for a minimum of 5 days to a maximum of 7 days.

DRUG

Tacrolimus

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Arthur Matas, MD · University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-04-30
Completion
2004-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00007787 on ClinicalTrials.gov