Benefit of Early Protocol Biopsy and Treatment of Subclinical Rejection

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma Canada, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00885820
First received: April 20, 2009
Last updated: September 17, 2014
Last verified: September 2014
  Purpose

This multicentre randomized, controlled trial (RCT) compared renal allograft histology and function in subjects treated with Tacrolimus + MMF + prednisone undergoing early protocol biopsies and treatment of subclinical rejection versus a non-protocol biopsy control group.


Condition Intervention Phase
Kidney Transplantation
Drug: Tacrolimus
Drug: MMF
Drug: Corticosteroids (Prednisone)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effects of Treatment of Subclinical Rejection on Renal Histology and Graft Function in Renal Transplant Patients Receiving Tacrolimus and Mycophenolate Mofetil

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • The incidence of interstitial fibrosis/tubular atrophy as defined by Banff interstitial and tubular chronic changes of ci + ct of 2 or more at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The incidence of subclinical rejection at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Prevalence of chronic renal histopathology at 24 months [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Renal function as determined by serum creatinine and 24 hour urine creatinine clearance and protein excretion [ Time Frame: 6, 12 and 24 moths ] [ Designated as safety issue: No ]

Enrollment: 240
Study Start Date: September 2001
Study Completion Date: January 2006
Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Protocol biopsies at 1, 2 and 3 months
Drug: Tacrolimus
Oral
Other Names:
  • Prograf
  • FK506
Drug: MMF
Oral
Other Name: Cellcept
Drug: Corticosteroids (Prednisone)
Oral
Other Names:
  • Methylprednisolone
  • Prednisone
Active Comparator: 2
No protocol biopsies
Drug: Tacrolimus
Oral
Other Names:
  • Prograf
  • FK506
Drug: MMF
Oral
Other Name: Cellcept
Drug: Corticosteroids (Prednisone)
Oral
Other Names:
  • Methylprednisolone
  • Prednisone

  Eligibility

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

Inclusion Criteria:

  • Subject is the recipient of a first or second cadaveric or living donor mismatched (at least one mismatch) renal 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 over 65 years of age
  • Recipient of non-related donor kidney with peak pre-transplant PRA > 50
  • Subject has lost a previous graft to rejection less than one year from transplant
  • Subject who has received an investigational drug within three months prior to randomization
  • Subjects who are pregnant or breastfeeding
  • Subject receives a kidney lacking a pre-implantation biopsy
  • Subject has significant disease or disability (e.g. malignancy or uncontrolled infection) which prevents adherence to the protocol
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00885820

Locations
United States, California
Palo Alto, California, United States, 94304-1510
Canada, Alberta
Calgary, Alberta, Canada, T2N 2T9
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
Vancouver, British Columbia, Canada, V5Z 1M9
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Manitoba
Winnipeg, Manitoba, Canada, R3A 1R9
Canada, Ontario
Hamilton, Ontario, Canada, L8N 4A6
Ottawa, Ontario, Canada, K1H 7W9
Canada, Quebec
Montreal, Quebec, Canada, H1T 2M4
Montreal, Quebec, Canada, H2L 4M1
Quebec City, Quebec, Canada, G1R 2J6
Canada, Saskatchewan
Saskatoon, Saskatchewan, Canada, S7M 0Z9
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma Canada, Inc.
Investigators
Study Director: Use Central Contact Astellas Pharma Canada, Inc.
  More Information

Additional Information:
Publications:
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00885820     History of Changes
Other Study ID Numbers: FKC-008
Study First Received: April 20, 2009
Last Updated: September 17, 2014
Health Authority: Canada: Health Canada
United States: Institutional Review Board

Keywords provided by Astellas Pharma Inc:
Kidney Transplantation
Tacrolimus
Immunosuppression
Graft Survival

Additional relevant MeSH terms:
Methylprednisolone
Prednisone
Tacrolimus
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Immunosuppressive Agents
Neuroprotective Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014