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A Study to Assess the Safety and Efficacy of Prograf and MR4 in Kidney Transplantation Patients

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.
ClinicalTrials.gov Identifier: NCT00720265
Recruitment Status : Completed
First Posted : July 22, 2008
Last Update Posted : July 22, 2008
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
To prove non-inferiority of MR4 to Prograf by evaluating the efficacy and safety of Prograf and MR4 in new kidney transplant recipients

Condition or disease Intervention/treatment Phase
Kidney Transplantation Drug: Prograf Drug: MR4 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A PHASE III, Randomized, Open-Label, Comparative, Multi - Center Study to Assess the Safety and Efficacy of Prograf® (Tacrolimus) and MR4 (Modified Release Tacrolimus) in de Novo Kidney Transplant Recipients
Study Start Date : February 2006
Primary Completion Date : March 2008
Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1 Drug: Prograf
oral
Other Names:
  • Tacrolimus
  • FK506
Experimental: 2 Drug: MR4
oral
Other Names:
  • Modified Release Tacrolimus
  • FK506MR
  • FK506E


Outcome Measures

Primary Outcome Measures :
  1. Acute rejection within 24 weeks (6 months) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Incidence of biopsy-proven acute rejection (Banff Grade ≥ 1) [ Time Frame: at 6 months ]
  2. Time to first acute rejection episode [ Time Frame: for 6 months ]
  3. 6 month patient and graft survival rate [ Time Frame: at 6 months ]
  4. Severity of acute rejection [ Time Frame: 6 months ]
  5. Adverse events, laboratory parameters and vital signs [ Time Frame: Throughout trial ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient must receive first oral dose of randomized study drug 2days(min 1day) prior to transplant procedure
  • Female patients of child bearing potential must have a negative urine or serum pregnancy test within 7 days prior to enrollment

Exclusion Criteria:

  • Patient has previously received an organ transplant other than a kidney
  • Patient has received a Kidney transplant from non-heart beating donor or a cadaveric donor
  • Patients has received an ABO incompatible donor kidney
  • Recipient or donor is known to be seropositive for human immunodeficiency virus(HIV)
  • Patient has a current malignancy or a history of malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully
  • Patient has significant liver, disease, defined as having during the past 28 days continuously elevated AST (SGOT) and/or ALT (SGPT) levels greater than 3 times the upper value of the normal range of the investigational site
  • Patient has an uncontrolled concomitant infection(including Hepatitis B, Hepatitis C)or any other unstable medical condition that could interfere with the study objectives
  • Patient is currently taking or has been taking an immunosuppressive agents in the 30 days prior to transplant(except from two days prior to transplant)
  • Patient has a known hypersensitivity to tacrolimus
  • Patient is pregnant or lactating
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00720265


Locations
Korea, Republic of
Daegu, Korea, Republic of
Seoul, Korea, Republic of
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma Korea, Inc.
Investigators
Study Chair: Central Contact Astellas Pharma Korea, Inc.
More Information

Responsible Party: Director, Astellas Pharma, Inc
ClinicalTrials.gov Identifier: NCT00720265     History of Changes
Other Study ID Numbers: MR-05-01-KOR
First Posted: July 22, 2008    Key Record Dates
Last Update Posted: July 22, 2008
Last Verified: July 2008

Keywords provided by Astellas Pharma Inc:
Organ Transplantation
Tacrolimus
Prograf
FK506MR

Additional relevant MeSH terms:
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action