Campath-1H/Tacrolimus/Sirolimus Withdrawal in Renal Transplantation - Full Text View

Sponsored by:	University of Wisconsin, Madison
Information provided by:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00585130

Purpose

To investigate the safety and efficacy of a treatment regimen consisting of induction therapy with Campath-1H and tacrolimus, followed by sirolimus monotherapy in renal transplant patients, and to evaluate this regimen's potential to enable the eventual discontinuation of long-term immunosuppressive therapy.

Condition	Intervention
Kidney Transplantation	Drug: Campath, sirolimus

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Sirolimus Tacrolimus Campath Alemtuzumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	The Use of Campath-1H, Tacrolimus, and Sirolimus Followed by Sirolimus Withdrawal in Renal Transplant Patients

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:

Incidence of acute rejection [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Incidence of death, graft loss, or acute rejection stratified by sirolimus withdrawal [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	10
Study Start Date:	August 2003
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Campath induction, tacrolimus for 2 months, then sirolimus monotherapy (followed by sirolimus withdrawal at 1 year if eligible)	Drug: Campath, sirolimus Campath-1H 30mg POD 0 and 1, sirolimus monotherapy, weaned at 1 year if eligible

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female patients aged 18 to 65 years who are to receive a single-organ renal transplant (0-3 HLA antigen mismatch).

Exclusion Criteria:

Recipients of HLA-identical living-donor renal transplants
HLA-antigen mismatch greater than 3
PRA value > 10% at any time prior to enrollment
Recipients of a non-heart-beating donor allografts
Recipients of a kidney from a donor who is greater than 60 years of age
ESRD due to FSGS
Previous renal transplant
Multi-organ transplant
Concomitant systemic corticosteroid therapy for other medical diseases
Pregnant or nursing mothers
Known hypersensitivity to Campath-1H, tacrolimus, methylprednisolone, or sirolimus
Positive HIV (within 1 year prior to transplantation), Hepatitis C or Hepatitis B surface antigen
Recipient of dual or en-bloc pediatric kidneys
Positive for AHG or T-cell crossmatch
Therapy with an investigational drug within 6 weeks of study entry
Known clinically significant cardiovascular or cerebrovascular disease
Previous or current history of malignancies and lymphoma, excluding adequately treated skin carcinoma (basal or squamous cell)
Clinically significant coagulopathy or a requirement for chronic anticoagulation therapy precluding biopsy
CMV-negative recipients of a kidney from a CMV-positive donor
History of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study
Patients with Graves disease will be excluded unless previously adequately treated with radioiodine ablative therapy
Patients with active systemic infections
Patients with a platelet count < 100,000/mm3 at study entry.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00585130

Locations

United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792

Sponsors and Collaborators

University of Wisconsin, Madison

Investigators

Principal Investigator:

Stuart Knechtle, MD

University of Wisconsin, Madison

More Information

No publications provided

Responsible Party:	University of Wisconsin ( Stuart Knechtle, MD )
Study ID Numbers:	2003-0435, ITN013ST
Study First Received:	December 26, 2007
Last Updated:	January 2, 2008
ClinicalTrials.gov Identifier:	NCT00585130 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Sirolimus
Anti-Bacterial Agents
Immunologic Factors
Clotrimazole
Miconazole

Antifungal Agents
Alemtuzumab
Tioconazole
Tacrolimus
Immunosuppressive Agents

Additional relevant MeSH terms:

Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Immunologic Factors
Antineoplastic Agents
Antifungal Agents

Therapeutic Uses
Alemtuzumab
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009