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

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma Korea, Inc.
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00720265
First received: July 18, 2008
Last updated: NA
Last verified: July 2008
History: No changes posted
  Purpose

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


Condition Intervention Phase
Kidney Transplantation
 Drug: Prograf
Drug: MR4
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

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

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Acute rejection within 24 weeks (6 months) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of biopsy-proven acute rejection (Banff Grade ≥ 1) [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
  • Time to first acute rejection episode [ Time Frame: for 6 months ] [ Designated as safety issue: No ]
  • 6 month patient and graft survival rate [ Time Frame: at 6 months ] [ Designated as safety issue: Yes ]
  • Severity of acute rejection [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Adverse events, laboratory parameters and vital signs [ Time Frame: Throughout trial ] [ Designated as safety issue: Yes ]

Enrollment: 135
Study Start Date: February 2006
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: Prograf
oral
Other Names:
  • Tacrolimus
  • FK506
Experimental: 2 Drug: MR4
oral
Other Names:
  • Modified Release Tacrolimus
  • FK506MR
  • FK506E

  Eligibility

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Director, Astellas Pharma, Inc
ClinicalTrials.gov Identifier: NCT00720265     History of Changes
Other Study ID Numbers: MR-05-01-KOR
Study First Received: July 18, 2008
Last Updated: July 18, 2008
Health Authority: Korea: Food and Drug Administration

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

Additional relevant MeSH terms:
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013