Study of Tacrolimus Immunosuppressive Therapy After Kidney Transplantation - Full Text View

Purpose

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.

Condition	Intervention	Phase
Kidney Transplantation Kidney Failure, Chronic Renal Insufficiency, Chronic	Drug: Tacrolimus Drug: Mycophenolate Mofetil Drug: Methylprednisolone or equivalent Drug: Prednisone	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Open-Label, Randomized, Multicenter, Parallel-Group Efficacy and Safety Study of Tacrolimus Immunosuppressive Therapy After Kidney Transplantation

Resource links provided by NLM:

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Incidence and time to first biopsy-proven acute rejection [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Overall frequency of acute rejection episodes within 6 months post transplantation [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Severity of biopsy proven acute rejections (BANFF criteria) within 6 months post transplantation [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Incidence of and time to first corticosteroid-resistant acute rejection [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Subject and graft survival [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment:	50
Study Start Date:	May 2007
Study Completion Date:	October 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 steroid regimen 1	Drug: Tacrolimus oral Other Names: Prograf FK506 Drug: Mycophenolate Mofetil oral Other Name: 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 Name: MMF Drug: Methylprednisolone or equivalent oral Drug: Prednisone oral

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00717379

Locations

Russian Federation

Moscow, Russian Federation, 119992

Moscow, Russian Federation, 123182

Moscow, Russian Federation, 115446

Omsk, Russian Federation, 644112

St. Petersburg, Russian Federation, 197110

Volzskii, Russian Federation, 404120

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Director:

Central Contact

ZAO Astellas Pharma Russia

More Information

No publications provided

Responsible Party:	Disclosure Office Europe, Astellas Pharma Europe BV
ClinicalTrials.gov Identifier:	NCT00717379 History of Changes
Other Study ID Numbers:	PRG-EC-2R01
Study First Received:	July 16, 2008
Last Updated:	April 13, 2009
Health Authority:	Russia: Ministry of Health of the Russian Federation

Keywords provided by Astellas Pharma Inc:

Organ Transplantation
Tacrolimus
Prograf
Kidney
Immunosuppression

Additional relevant MeSH terms:

Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Immunosuppressive Agents
Mycophenolate mofetil
Tacrolimus
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisone
Prednisolone hemisuccinate

Prednisolone phosphate
Mycophenolic Acid
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Glucocorticoids

ClinicalTrials.gov processed this record on May 19, 2013