A Study to Compare the Efficacy and Safety of FK506MR vs Prograf® in Patients Undergoing Kidney Transplantation - Full Text View

Sponsor:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00481819

Purpose

The patients about to undergo kidney transplantation will be randomized to one of the following two group:

Group FK506MR: FK506MR/MMF/steroid; Group Prograf® : Prograf® /MMF/steroid. The treatment period is 3 months( 12 weeks)

Condition	Intervention	Phase
Kidney Transplantation	Drug: FK506MR Drug: Prograf Drug: Mycophenolate Mofetil Drug: Methylprednisolone Drug: Prednisolone	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	A Multicenter, Randomized, Open Label, Parallel Study to Evaluate and Compare the Efficacy and Safety of FK506MR vs Prograf® in Combination With MMF and Steroids in Patients Undergoing Kidney Transplantation and a Pharmacokinetics Study.

Resource links provided by NLM:

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Prednisolone Prednisolone acetate Depo-medrol Medrol veriderm Methylprednisolone Tacrolimus anhydrous Tacrolimus Mycophenolate mofetil hydrochloride Mycophenolate Mofetil Prednisolone sodium phosphate Prednisolone Sodium Succinate Methylprednisolone Sodium Succinate Methylprednisolone hemisuccinate 6-Methylprednisolone

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Event rate of patients with acute rejections [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Incidence of and time to acute rejections [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
Overall frequency of acute rejections [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
Rate of patient and graft survival following transplantation [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]

Enrollment:	240
Study Start Date:	July 2007
Study Completion Date:	March 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 In combination with MMF and steroids	Drug: FK506MR oral Other Names: Advagraf Tacrolimus modified-release MR4 Drug: Mycophenolate Mofetil oral Other Name: MMF Drug: Methylprednisolone oral Drug: Prednisolone oral
Active Comparator: 2 In combination with MMF and steroids	Drug: Prograf oral Other Names: tacrolimus FK506 Drug: Mycophenolate Mofetil oral Other Name: MMF Drug: Methylprednisolone oral Drug: Prednisolone oral

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Written informed consent with the date of the patient must be obtained.
Patient between 18-70 years of age receiving the primary kidney.
Female patients must have a negative pregnancy test prior to the enrolment.
Female patients of child bearing potential must agree to practice effective birth control during the study.

Exclusion Criteria:

Kidney re-transplantation patients or received an organ transplantation other than a kidney.
PRA>10% in the previous 6 months.
Patient who need antibody induction therapy.
Patient with significant liver disease, defined as having continuously elevated >2 times of SGPT and/or SGOT and/or total bilirubin levels during the past 28 days.
Patient with severe infection requiring treatment, and/or severe diarrhea, vomiting, active upper gastrointestinal tract malabsorption or active peptic ulcer.
Patient has any history of severe cardiovascular, respiratory disease; or history of malignancy.
Patient is HIV or HBsAg positive.
Patient is allergic to Prograf or macrolide antibiotics.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00481819

Locations

China, Beijing
3 Sites
Beijing, Beijing, China
China, Fujian

Fuzhou, Fujian, China
China, Guangdong
2 Sites
Guangzhou, Guangdong, China
China, Hubei

Wuhan, Hubei, China
China, Hunan

Changsha, Hunan, China
China, Liaoning

Shenyang, Liaoning, China
China, Shanghai
2 Sites
Shanghai, Shanghai, China
China, Sichuan

Chongqing, Sichuan, China
China, Zheijiang

Hangzhou, Zheijiang, China

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Principal Investigator:

Prof. Ao Jianhua

Department of Urologic Surgery

More Information

No publications provided

Responsible Party:	Director, Astellas Pharma, Inc
ClinicalTrials.gov Identifier:	NCT00481819 History of Changes
Other Study ID Numbers:	MR4KTxCN01
Study First Received:	May 31, 2007
Last Updated:	March 10, 2009
Health Authority:	China: State Food and Drug Administration

Keywords provided by Astellas Pharma Inc:

Kidney Transplantation
Tacrolimus
Methylprednisolone
Prednisolone
Mycophenolate Mofetil

Additional relevant MeSH terms:

Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone phosphate
Mycophenolic Acid
Mycophenolate mofetil
Tacrolimus
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Immunosuppressive Agents
Immunologic Factors
Antibiotics, Antineoplastic
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 12, 2012