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

NCT00720265 | Completed Phase 3

• 1 other identifier: MR-05-01-KOR
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 2

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

Conditions

Kidney Transplantation

Keywords

Organ Transplantation; Tacrolimus; Prograf; FK506MR

Outcome Measures

Primary Outcomes (1)

• Acute rejection within 24 weeks (6 months)

  6 months

Secondary Outcomes (5)

• Incidence of biopsy-proven acute rejection (Banff Grade ≥ 1)

  at 6 months

• Time to first acute rejection episode

  for 6 months

• 6 month patient and graft survival rate

  at 6 months

• Severity of acute rejection

  6 months

• Adverse events, laboratory parameters and vital signs

  Throughout trial

Study Arms (2)

1

ACTIVE COMPARATOR

Drug: Prograf

2

EXPERIMENTAL

Drug: MR4

Interventions

Prograf DRUG

oral

Also known as: Tacrolimus, FK506

1

MR4 DRUG

oral

Also known as: Modified Release Tacrolimus, FK506MR, FK506E

2

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead
• Astellas Pharma Korea, Inc.: collaborator

Study Sites (2)

Unknown Facility

Daegu, South Korea

Location

Unknown Facility

Seoul, South Korea

Location

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Central Contact

  Astellas Pharma Korea, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 18, 2008
• First Posted: July 22, 2008
• Study Start: February 1, 2006
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: July 22, 2008

Record last verified: 2008-07

Locations

KR (2)