Trials Sponsors Conditions Drugs Pricing

Conditions

Kidney Transplantation Transplantation Immunology Host vs Graft Reaction

Keywords

ImmunosuppressantCombination drug therapyGraft lossRandomized controlled trialOpen level method

Outcome Measures

Primary Outcomes (1)

The patient and graft survival rates at 6 month post-transplant
6 months

Secondary Outcomes (3)

Efficacy failure at 6-month posttransplant.
6 months
Incidence of biopsy confirmed acute rejection (Banff > 1) at 6 months and 12 months
6 months and 12 months
1 year patient and graft survival

Study Arms (2)

Prograf-XL + MMF

EXPERIMENTAL

Drug: Prograf-XLDrug: MMF

Prograf + MMF

ACTIVE COMPARATOR

Drug: PrografDrug: MMF

Interventions

Prograf-XLDrug

oral

Also known as: tacrolimus extended release, FK506XL, MR4

Prograf-XL + MMF

PrografDrug

oral

Also known as: tacrolimus, FK506

Prograf + MMF

Eligibility Criteria

Age12 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Patient has been fully informed and has signed an IRB approved informed consent form and is willing and able to follow study procedures
Patient is a recipient of a primary or retransplanted cadaveric or non-HLA-identical living kidney transplant

Sponsors & Collaborators

Astellas Pharma Taiwan, Inc.
Industrycollaborator
Astellas Pharma Inc
Industrylead

Study Sites (5)

Taichung, 407, Taiwan

Tainan, 704, Taiwan

Taipei, 100, Taiwan

Taipei, 112, Taiwan

Taoyuan, 333, Taiwan

MeSH Terms

Interventions

TacrolimusMycophenolic Acid

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic ChemicalsCaproatesAcids, AcyclicCarboxylic AcidsFatty AcidsLipids

Study Officials

Central Contact
Astellas Pharma Inc
STUDY CHAIR

Enrollment

73 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 16, 2008

First Posted

July 17, 2008

Study Start

December 2007

Date type not reported

This date has not been verified as actual or estimated.

A Randomized Study to Assess the Safety and Efficacy of Prograf vs Prograf-XL in de Novo Kidney Transplant Recipients

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Prograf-XL + MMF

Prograf + MMF

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (5)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Prograf-XL + MMF

Prograf + MMF

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (5)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations