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

Sponsored by:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00717379

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 IV

MedlinePlus related topics: Kidney Failure Kidney Transplantation

Drug Information available for: Methylprednisolone Prednisone Tacrolimus Mycophenolate Mofetil Mycophenolate mofetil hydrochloride Tacrolimus anhydrous

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Open-Label, Randomized, Multicenter, Parallel-Group Efficacy and Safety Study of Tacrolimus Immunosuppressive Therapy After Kidney Transplantation

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
Estimated Study Completion Date:	October 2008
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator steroid regimen 1	Drug: Tacrolimus oral Drug: Mycophenolate Mofetil oral Drug: Methylprednisolone or equivalent oral Drug: Prednisone oral
2: Experimental steroid regimen 2	Drug: Tacrolimus oral Drug: Mycophenolate Mofetil oral 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

St. Petersburg, Russian Federation, 197110

Moscow, Russian Federation, 123182

Moscow, Russian Federation, 115446

Omsk, Russian Federation, 644112

Volzskii, Russian Federation, 404120

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Director:

Central Contact

ZAO Astellas Pharma Russia

More Information

Responsible Party:	Astellas Pharma Europe BV ( Disclosure Office Europe )
Study ID Numbers:	PRG-EC-2R01
Study First Received:	July 16, 2008
Last Updated:	July 16, 2008
ClinicalTrials.gov Identifier:	NCT00717379
Health Authority:	Russia: Ministry of Health and Social Development of the Russian Federation

Keywords provided by Astellas Pharma Inc:

Organ Transplantation
Tacrolimus
Prograf
Kidney
Immunosuppression

Study placed in the following topic categories:

Prednisone
Renal Insufficiency
Methylprednisolone
Kidney Failure, Chronic
Methylprednisolone acetate
Prednisolone acetate
Tacrolimus

Urologic Diseases
Renal Insufficiency, Chronic
Prednisolone
Mycophenolate mofetil
Kidney Diseases
Methylprednisolone Hemisuccinate
Kidney Failure

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immunologic Factors
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Gastrointestinal Agents
Antiemetics
Immunosuppressive Agents

Neuroprotective Agents
Protective Agents
Glucocorticoids
Hormones
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009