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:


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
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: 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 October 16, 2014