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Benefit of Early Protocol Biopsy and Treatment of Subclinical Rejection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00885820
Recruitment Status : Completed
First Posted : April 22, 2009
Last Update Posted : September 18, 2014
Astellas Pharma Canada, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:
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 or disease Intervention/treatment Phase
Kidney Transplantation Drug: Tacrolimus Drug: MMF Drug: Corticosteroids (Prednisone) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : September 2001
Actual Primary Completion Date : July 2004
Actual Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus

Arm Intervention/treatment
Experimental: 1
Protocol biopsies at 1, 2 and 3 months
Drug: Tacrolimus
Other Names:
  • Prograf
  • FK506

Drug: MMF
Other Name: Cellcept

Drug: Corticosteroids (Prednisone)
Other Names:
  • Methylprednisolone
  • Prednisone

Active Comparator: 2
No protocol biopsies
Drug: Tacrolimus
Other Names:
  • Prograf
  • FK506

Drug: MMF
Other Name: Cellcept

Drug: Corticosteroids (Prednisone)
Other Names:
  • Methylprednisolone
  • Prednisone

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. The incidence of subclinical rejection at 6 months [ Time Frame: 6 months ]
  2. Prevalence of chronic renal histopathology at 24 months [ Time Frame: 24 months ]
  3. Renal function as determined by serum creatinine and 24 hour urine creatinine clearance and protein excretion [ Time Frame: 6, 12 and 24 moths ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00885820

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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.
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Study Director: Use Central Contact Astellas Pharma Canada, Inc.
Additional Information:
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Responsible Party: Astellas Pharma Inc Identifier: NCT00885820    
Other Study ID Numbers: FKC-008
First Posted: April 22, 2009    Key Record Dates
Last Update Posted: September 18, 2014
Last Verified: September 2014
Keywords provided by Astellas Pharma Inc:
Kidney Transplantation
Graft Survival
Additional relevant MeSH terms:
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Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents