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Study of Tacrolimus Immunosuppressive Therapy After Kidney Transplantation

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ClinicalTrials.gov Identifier: NCT00717379
Recruitment Status : Completed
First Posted : July 17, 2008
Last Update Posted : April 15, 2009
Sponsor:
Information provided by:
Astellas Pharma Inc

Brief Summary:
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 or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label, Randomized, Multicenter, Parallel-Group Efficacy and Safety Study of Tacrolimus Immunosuppressive Therapy After Kidney Transplantation
Study Start Date : May 2007
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Incidence and time to first biopsy-proven acute rejection [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Overall frequency of acute rejection episodes within 6 months post transplantation [ Time Frame: 6 months ]
  2. Severity of biopsy proven acute rejections (BANFF criteria) within 6 months post transplantation [ Time Frame: 6 months ]
  3. Incidence of and time to first corticosteroid-resistant acute rejection [ Time Frame: 6 months ]
  4. Subject and graft survival [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00717379


Locations
Russian Federation
Moscow, Russian Federation, 115446
Moscow, Russian Federation, 119992
Moscow, Russian Federation, 123182
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

Responsible Party: Disclosure Office Europe, Astellas Pharma Europe BV
ClinicalTrials.gov Identifier: NCT00717379     History of Changes
Other Study ID Numbers: PRG-EC-2R01
First Posted: July 17, 2008    Key Record Dates
Last Update Posted: April 15, 2009
Last Verified: April 2009

Keywords provided by Astellas Pharma Inc:
Organ Transplantation
Tacrolimus
Prograf
Kidney
Immunosuppression

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Prednisolone acetate
Methylprednisolone acetate
Prednisone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Mycophenolic Acid
Tacrolimus
Immunosuppressive Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunologic Factors
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Antibiotics, Antitubercular
Antitubercular Agents