Study of Tacrolimus Immunosuppressive Therapy After Kidney Transplantation

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00717379
First received: July 16, 2008
Last updated: April 13, 2009
Last verified: April 2009
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Renal Insufficiency
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Tacrolimus
Mycophenolate mofetil
Immunosuppressive Agents
Mycophenolic Acid
Methylprednisolone Hemisuccinate
Prednisolone
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on September 18, 2014