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Completed

NCT Number: NCT00720265

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

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

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Key information

Conditions

Kidney Transplantation

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Daegu, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prograf

Drug

oral

Other names: Tacrolimus, FK506

MR4

Drug

oral

Other names: Modified Release Tacrolimus, FK506MR, FK506E

Primary outcomes

  1. Acute rejection within 24 weeks (6 months)

    Time frame: 6 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Collaborators

  • Astellas Pharma Korea, Inc.

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jul 22, 2008
Registry last updated
Jul 22, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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