NCT00407160

Brief Summary

Comparison between Campath induction and monotherapy with Tacrolimus vs Thymoglobulin induction and triple drug maintenance using Tacrolimus, mycophenolate, and steroids.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2004

Longer than P75 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

November 21, 2006

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 4, 2006

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

March 4, 2019

Status Verified

December 1, 2012

Enrollment Period

6.4 years

First QC Date

November 21, 2006

Last Update Submit

February 28, 2019

Conditions

Kidney Diseases

Keywords

Kidney transplantTolerance inductionHigh Panel Reactive Antibody (PRA) kidney recipients

Outcome Measures

Primary Outcomes (1)

  • graft survival

    Cumulative graft survival at 1 year

    1 year

Secondary Outcomes (1)

  • rejection episodes

    1 year

Study Arms (2)

Group 1 Standard Immunosuppression

Anti-thymocyte Globulin (Rabbit)\] ,tacrolimus, mycophenolate mofetil and prednisone Patients with End Stage Renal Disease (ESRD) and high Panel Reactive Antibody (PRA) who randomize to the control group. These patients will get induction therapy prior to transplant with Thymoglobulin 1.5 mg/kg/day for 4 days to a total dose of 6mg/kg. They will receive maintenance immunosuppression with three drugs : tacrolimus, cellcept and prednisone.

Group 2 Campath Immunosuppression

Alemtuzumab,tacrolimus Patients with ESRD and high PRA who randomize to the study group. These patients will get induction therapy prior to reperfusion of the kidney, during the transplant operation, with Campath (Alemtuzumab) 30mg, one dose. They will receive maintenance immunosuppression with tacrolimus alone (monotherapy).

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with end stage renal disease , on dialysis, who are regarded as "high immunological risk" becuase they have lost previous transplants to rejection, or have a high panel reactive antibody (PRA).

You may qualify if:

  • Males and females aged 18-75 years.
  • Recipients of multiple kidney transplants
  • Patients with a PRA \>14% and/or a past historical PRA greater or equal to 50%.
  • Patients who are willing and able to participate in the full course of the study and from whom written informed consent has been obtained.

You may not qualify if:

  • Patients with a history of malignancy within the last 5 years, except excised squamous or basal cell carcinoma of the skin.
  • Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after contraception and until the termination of gestation,confirmed by a positive human chorionic gonadotropin(hCG) laboratory test.
  • Patients who are HIV positive.
  • Patients with symptoms of significant somatic or mental illness or evidence of current drug and/or alcohol abuse.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555-0533, United States

Location

Related Publications (3)

  • Calne RY. Prope tolerance: a step in the search for tolerance in the clinic. World J Surg. 2000 Jul;24(7):793-6. doi: 10.1007/s002680010127.

    PMID: 10833245BACKGROUND

  • Magliocca JF, Knechtle SJ. The evolving role of alemtuzumab (Campath-1H) for immunosuppressive therapy in organ transplantation. Transpl Int. 2006 Sep;19(9):705-14. doi: 10.1111/j.1432-2277.2006.00343.x.

    PMID: 16918530BACKGROUND

  • Thomas PG, Woodside KJ, Lappin JA, Vaidya S, Rajaraman S, Gugliuzza KK. Alemtuzumab (Campath 1H) induction with tacrolimus monotherapy is safe for high immunological risk renal transplantation. Transplantation. 2007 Jun 15;83(11):1509-12. doi: 10.1097/01.tp.0000263344.53000.a1.

    PMID: 17565326DERIVED

MeSH Terms

Conditions

Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Philip G Thomas, MD

    UTMB Department of Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2006

First Posted

December 4, 2006

Study Start

August 1, 2004

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

March 4, 2019

Record last verified: 2012-12

Locations

US(1)