Study of Tacrolimus Immunosuppressive Therapy After Kidney Transplantation

Open-Label, Randomized, Multicenter, Parallel-Group Efficacy and Safety Study of Tacrolimus Immunosuppressive Therapy After Kidney Transplantation

To compare the efficacy and safety of Tacrolimus in combination with MMF and Steroids in two regimens of steroid in an adult kidney transplanted population.

Study Overview

• Status: Completed
• Conditions: Renal Insufficiency, Chronic; Kidney Failure, Chronic; Kidney Transplantation
• Intervention / Treatment: Drug: Tacrolimus; Drug: Mycophenolate Mofetil; Drug: Methylprednisolone or equivalent; Drug: Prednisone

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 119992
  • Moscow, Russian Federation, 115446
  • Moscow, Russian Federation, 123182
  • Omsk, Russian Federation, 644112
  • St. Petersburg, Russian Federation, 197110
  • Volzskii, Russian Federation, 404120

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Female subject of childbearing potential must have a negative serum pregnancy test at enrolment and must agree to maintain effective birth control during the study
• Has an end stage kidney disease and is a suitable candidate for primary renal transplantation or retransplantation
• Subject is receiving a kidney transplant, from a cadaveric or living donor between 5 and 65 years of age with compatible AB0 blood type

Exclusion Criteria:

• Pregnant woman or breast-feeding mother
• Has an immunological high risk, defined as having a most recently measured PRA grade of > 50% within the previous six months
• Known allergy to the study drug or any of its components
• Requires ongoing dosing with a systemic immunosuppressive drug at study entry for any reason other than kidney transplantation
• Requires initial sequential or parallel therapy with immunosuppressive antibody preparation(s)
• Subject or donor is known to be HIV positive
• Has significant liver disease, defined as having during the past 28 days continuously elevated ASAT (SGOT) and/or ALAT (SGPT) levels greater than 3 times the upper value of the normal range of the investigational site
• Diagnosis of malignancy or history of malignancy, except non metastatic basal or squamous cell carcinoma of the skin that has been treated successfully
• Has significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting, or active peptic ulcer
• Previously received or is receiving an organ transplant other than kidney
• Receiving a graft from a non-heart-beating donor
• Cold ischemia time of the donor kidney >30 hours
• Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; steroid regimen 1	Drug: Tacrolimus; oral; Other Names: Prograf; FK506; Drug: Mycophenolate Mofetil; oral; Other Names: MMF; Drug: Methylprednisolone or equivalent; oral; Drug: Prednisone; oral
Experimental: 2; steroid regimen 2	Drug: Tacrolimus; oral; Other Names: Prograf; FK506; Drug: Mycophenolate Mofetil; oral; Other Names: MMF; Drug: Methylprednisolone or equivalent; oral; Drug: Prednisone; oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence and time to first biopsy-proven acute rejection	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall frequency of acute rejection episodes within 6 months post transplantation	6 months
Severity of biopsy proven acute rejections (BANFF criteria) within 6 months post transplantation	6 months
Incidence of and time to first corticosteroid-resistant acute rejection	6 months
Subject and graft survival	6 months

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc
• Investigators: Study Director: Central Contact, ZAO Astellas Pharma Russia

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Primary Completion (Actual): October 1, 2008
• Study Completion (Actual): October 1, 2008

Study Registration Dates

• First Submitted: July 16, 2008
• First Submitted That Met QC Criteria: July 16, 2008
• First Posted (Estimate): July 17, 2008

Study Record Updates

• Last Update Posted (Estimate): April 15, 2009
• Last Update Submitted That Met QC Criteria: April 13, 2009
• Last Verified: April 1, 2009

More Information

Terms related to this study

• Keywords: Immunosuppression; Tacrolimus; Prograf; Kidney; Organ Transplantation
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Renal Insufficiency; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antitubercular Agents; Antibiotics, Antitubercular; Calcineurin Inhibitors; Methylprednisolone; Prednisone; Tacrolimus; Mycophenolic Acid
• Other Study ID Numbers: PRG-EC-2R01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No