Effect of Rapid Steroid Withdrawal on Subclinical Markers of Rejection - Full Text View

Sponsors and Collaborators:	Astellas Pharma Inc Astellas Pharma Canada, Inc.
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00133172

Purpose

The purpose of this study is to compare the safety and efficacy of a tacrolimus-based 5-day steroid rapid withdrawal immunoprophylactic regimen in de novo renal transplantation.

Condition	Intervention	Phase
Kidney Transplantation	Drug: Tacrolimus Drug: mycophenolate mofetil Drug: Prednisone	Phase IV

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Prednisone Tacrolimus Mycophenolate Mofetil Mycophenolate mofetil hydrochloride Tacrolimus anhydrous

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Evaluation of the Long-Term Safety and Efficacy of a Tacrolimus-Based 5-Day Steroid Rapid Withdrawal Immunoprophylactic Regimen in de Novo Renal Transplantation

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Combined incidence of biopsy proven subclinical rejection (BPSCR) and biopsy proven clinical acute rejection (BPCAR) [ Time Frame: 3 months post transplant ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Biopsy proven chronic allograft nephropathy(CAN) [ Time Frame: 2 years post transplant ] [ Designated as safety issue: No ]
Patient and graft survival rates [ Time Frame: End of study (5 years) ] [ Designated as safety issue: No ]

Enrollment:	85
Study Start Date:	July 2005
Study Completion Date:	March 2007
Primary Completion Date:	March 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Steroid rapid 5-day withdrawal	Drug: Tacrolimus IV Drug: mycophenolate mofetil IV Drug: Prednisone IV
2: Active Comparator Standard steroid maintenance	Drug: Tacrolimus IV Drug: mycophenolate mofetil IV Drug: Prednisone IV

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject or legally acceptable guardian has signed and dated a Research Ethics Board (REB)-approved informed consent form and is willing and able to follow study procedures.
Subject is the recipient of a first or second cadaveric or living donor mismatched (at least one mismatch) renal transplant.
Subject is 18 years of age or over at the time of transplant.
If female and of child-bearing potential, subject has a negative pregnancy test and utilizes adequate contraceptive methods

Exclusion Criteria:

Recipients of a kidney from a donor 60 years of age or older
Recipients of donation after cardiac death (DCD) donors
Recipients of a combined transplant (e.g. kidney-pancreas, -lung, -heart)
Subjects with a second renal allograft who had their original graft for < 2 years, unless the initial graft was lost in the early (1 year or less) post transplant course due to a technical or surgical failure
Subjects with a current/latest pre-transplant panel of reactive antibodies (PRA) >20
Subjects with hepatitis B & C, HIV or cancer (excluding successfully excised squamous or basal cell carcinoma)
Subjects receiving an allograft with cold ischemia time 24 hours or greater
Subjects who have received an investigational drug within three months prior to randomization
Subjects who are breastfeeding
Subjects with known hypersensitivity to tacrolimus, mycophenolate mofetil, methylprednisolone, basiliximab, prednisone, or any related drugs or their excipients
Subjects with significant disease (e.g. uncontrolled infection) or disability (e.g. cognitive deficit) that prevents understanding of or adherence to the protocol

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00133172

Locations

Canada, Alberta

Calgary, Alberta, Canada, T2N 2T9

Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia

Vancouver, British Columbia, Canada, V5Z 1C6

Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Ontario

Ottawa, Ontario, Canada, K1H 7W9

London, Ontario, Canada, N6A 5A5

Toronto, Ontario, Canada, M5C2T2

Toronto, Ontario, Canada, M5G 2N2

Hamilton, Ontario, Canada, L8N 4A6
Canada, Quebec

Montreal, Quebec, Canada, H1T 2M4

Quebec City, Quebec, Canada, G1R 2J6

Montreal, Quebec, Canada, H2L 4M1

Montreal, Quebec, Canada, H3A 1A1
Canada, Saskatchewan

Saskatoon, Saskatchewan, Canada, S7M 0Z9

Sponsors and Collaborators

Astellas Pharma Inc

Astellas Pharma Canada, Inc.

Investigators

Study Director:

Medical Monitor

Astellas Pharma Canada, Inc.

More Information

Link to results on ClinicalStudyResults.org This link exits the ClinicalTrials.gov site

Responsible Party:	Astellas Pharma US, Inc. ( Sr Manager Clinical Trials Registry )
Study ID Numbers:	FKC-011
Study First Received:	August 22, 2005
Last Updated:	December 27, 2008
ClinicalTrials.gov Identifier:	NCT00133172
Health Authority:	Canada: Health Canada

Keywords provided by Astellas Pharma Inc:

Treatment Efficacy
Treatment Effectiveness
Anti-rejection therapy
Immunosuppression
Antirejection

Renal Transplantation
Transplantation, Renal
Transplantation, Kidney
Grafting, Kidney

Study placed in the following topic categories:

Prednisone
Mycophenolate mofetil
Tacrolimus

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immunologic Factors
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Hormones
Glucocorticoids
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009