NCT00007787

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2000

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2000

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2001

Completed
8 months until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2004

Completed
Last Updated

January 23, 2013

Status Verified

January 1, 2013

First QC Date

January 4, 2001

Last Update Submit

January 18, 2013

Conditions

Kidney TransplantationChronic Allograft Nephropathy

Outcome Measures

Primary Outcomes (1)

  • Graft function measurnment

    measured by a calculated creatinine clearance. Creatinine Clearance for males will be computed using the following: \[weight in kg \* (140 - age in years)\]/ \[72 \* serum creatinine mg/dl\]. For females, eighty-five percent of this value will be used.

    3 months

Study Arms (2)

Antibody plus delayed cyclosporine therapy

EXPERIMENTAL

Anti-human thymocyte globulin (rabbit) (Thymoglobulin®) is admistred at the time of transplant followed delayed clyclosporine A therapy post tranplant.

Biological: CyclosporineBiological: Anti-human thymocyte globulin (rabbit)Drug: Tacrolimus

Standard cyclosporine A therapy

ACTIVE COMPARATOR

Cyclosporine A therapy (either Cyclosporine or Tacrolimus) will be initiated pre-transplantations

Biological: CyclosporineDrug: Tacrolimus

Interventions

CyclosporineBIOLOGICAL
Antibody plus delayed cyclosporine therapyStandard cyclosporine A therapy
Anti-human thymocyte globulin (rabbit)BIOLOGICAL

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.

Also known as: Thymoglobulin®
Antibody plus delayed cyclosporine therapy
TacrolimusDRUG
Antibody plus delayed cyclosporine therapyStandard cyclosporine A therapy

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients may be eligible for this study if they:
  • Are receiving a first or second kidney transplant.
  • Are at least 21 years old.
  • Understand the purposes and risks of the study and have given consent.
  • Agree to use an acceptable form of birth control for a year following transplant.

You may not qualify if:

  • Patients will not be eligible for this study if they:
  • Have received a kidney transplant from a living donor.
  • Have had multiple organ transplants.
  • Are allergic to Thymoglobulin (contains a rabbit protein).
  • Are pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ilene Blechman-Krom

Rockville, Maryland, 20850, United States

Location

Related Links

MeSH Terms

Interventions

CyclosporinethymoglobulinTacrolimus

Intervention Hierarchy (Ancestors)

CyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and ProteinsMacrolidesLactonesOrganic Chemicals

Study Officials

  • Arthur Matas, MD

    University of Minnesota

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2001

First Posted

August 31, 2001

Study Start

April 1, 2000

Study Completion

March 1, 2004

Last Updated

January 23, 2013

Record last verified: 2013-01

Locations

US(1)