A Study in Kidney Transplant Subjects to Investigate the Optimal Suppression of Immunity to Help Prevent Kidney Rejection

Kidney Transplantation Clinical Trial

— OSAKA  

Official title:

A Multicenter, Four Arm, Randomized, Open Label Clinical Study Investigating Optimized Dosing in a Prograf®-/Advagraf®-Based Immunosuppressive Regimen in Kidney Transplant Subjects (OSAKA Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00717470
• Other study ID #: PMR-EC-1210
• Secondary ID: 2007-005376-13
• Status: Completed
• Phase: Phase 4
• First received: July 16, 2008
• Last updated: November 20, 2017
• Start date: May 14, 2008
• Est. completion date: March 2, 2010

Study information

• Verified date: November 2017
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare how well the new formulation of Tacrolimus® used once daily, in combination with other drugs helps prevent the rejection of a new kidney after transplantation compared to the twice daily dose of Tacrolimus

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1252
• Est. completion date: March 2, 2010
• Est. primary completion date: March 2, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• End stage kidney disease and a suitable candidate for primary renal transplantation or re-transplantation (unless the graft was lost from rejection within 12 months)

• Receiving a kidney transplant from a cadaveric or living (non HLA identical) donor with compatible ABO blood type

• Female subject of childbearing potential must have a negative serum pregnancy test at enrollment and must agree to maintain effective birth control during the study

Exclusion Criteria:

• Receiving or having previously received an organ transplant other than a kidney

• Cold ischemia time of the donor kidney > 30 hours

• Receiving a graft from a non-heart-beating donor other than of Maastricht category 3 (withdrawn of support awaiting cardiac arrest)

• Significant liver disease, defined as having continuously elevated SGPT/ALT and/or SGOT/AST and/or total bilirubin levels = 2 times the upper value of the normal range of the investigational site or is receiving a graft from a hepatitis C or B positive donor

• Requiring initial sequential or parallel therapy with immunosuppressive antibody preparation(s)

• Requiring ongoing dosing with a systemic immunosuppressive drug prior to transplantation.

• Significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer

• Pregnant woman or breast-feeding mother

• Subject or donor known to be HIV positive

• Known allergy or intolerance to tacrolimus, macrolide antibiotics, corticosteroids, basiliximab or mycophenolate mofetil or any of the product excipients

• Diagnosis of new-onset malignancy prior to transplantation, with the exception of basocellular or squamous cell carcinoma of the skin which had been treated successfully

• Currently participating in another clinical trial, and/or has taken an investigational drug within 28 days prior to enrollment

• Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the investigator

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Drug:
• Prograf®
oral
• Advagraf®
oral
• Mycophenolate Mofetil
oral
• Simulect
oral
• methylprednisolone / prednisone
oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Countries where clinical trial is conducted

Argentina,  Austria,  Belgium,  Czechia,  France,  Germany,  Greece,  Hungary,  Ireland,  Italy,  Netherlands,  Norway,  Poland,  Portugal,  Romania,  Russian Federation,  Slovakia,  South Africa,  Spain,  Sweden,  Switzerland,  United Kingdom, 

References & Publications (1)

Albano L, Banas B, Klempnauer JL, Glyda M, Viklicky O, Kamar N; Optimising immunoSuppression After Kidney transplantation with ADVAGRAF Study Group. OSAKA trial: a randomized, controlled trial comparing tacrolimus QD and BD in kidney transplantation. Transplantation. 2013 Nov 27;96(10):897-903. doi: 10.1097/TP.0b013e3182a203bd. Erratum in: Transplantation. 2014 Mar 27;97(6):38. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy failure rate		24 weeks
Secondary	Renal Function, acute rejection, Biopsy confirmed acute rejection		24 weeks

External Links

•   Link to results on Astellas Clinical Study Results website