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

Kidney Transplantation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00720265
• Other study ID #: MR-05-01-KOR
• Status: Completed
• Phase: Phase 3
• First received: July 18, 2008
• Last updated: July 18, 2008
• Start date: February 2006
• Est. completion date: March 2008

Study information

• Verified date: July 2008
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Drug:
• Prograf
oral
• MR4
oral

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Astellas Pharma Inc	Astellas Pharma Korea, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute rejection within 24 weeks (6 months)		6 months	No
Secondary	Incidence of biopsy-proven acute rejection (Banff Grade = 1)		at 6 months	No
Secondary	Time to first acute rejection episode		for 6 months	No
Secondary	6 month patient and graft survival rate		at 6 months	Yes
Secondary	Severity of acute rejection		6 months	No
Secondary	Adverse events, laboratory parameters and vital signs		Throughout trial	Yes