Comparison of a Tacrolimus Hexal® Based Regimen Versus a Prograf® Based Regimen in de Novo Renal Transplant Recipients

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-17

Study Completion Date

2015-08-20

Brief Summary

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The purpose of this study was to investigate if Tacrolimus Hexal® has similar pharmacokinetic properties compared to Prograf® in de novo renal transplant patients and whether the comparable exposure resulted in similar renal function.

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Detailed Description

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In Phase II of this study there was a high patient drop-out rate and an associated long recruitment timespan. Eighty-one patients were recruited to Phase I and only 45 of the required 54 patients were available for PK analysis. To complete Phase II, 245 (in addition to 81) patients were to be required to achieve calculated sample size. Therefore the protocol was amended to stop recruitment and analyze Phase I patient data of CERL080ADE27 (PK-Phase I). Patients that were still ongoing were scheduled for an end of study (EOS) visit. During this visit patients were informed by the investigator about the end of study and advised about further treatment course.

Conditions

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Pharmacokinetics Study in de Novo Kidney Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Prograf

Control therapy: one capsule containing 0.5 mg, 1mg or 5mg Prograf®, one tablet containing 180mg or 360mg Myfortic®, corticosteroids and one vial containing 20mg lyophilisate Simulect®

Group Type EXPERIMENTAL

Prograf

Intervention Type DRUG

Prograf® capsules were supplied as capsules of 0.5 mg, 1 mg and 1.5 mg dose strengths.

Tacroliums Hexal

Investigational therapy: one capsule containing 0.5mg, 1mg or 5mg Tacrolimus Hexal®, one tablet containing 180mg or 360mg Myfortic®, corticosteroids and one vial containing 20mg lyophilisate Simulect®

Group Type EXPERIMENTAL

Tacrolimus Hexal

Intervention Type DRUG

Tacrolimus Hexal® capsules were supplied to the investigators at dose strengths of 0.5 mg,

1 mg and 1.5 mg.

Interventions

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Prograf

Prograf® capsules were supplied as capsules of 0.5 mg, 1 mg and 1.5 mg dose strengths.

Intervention Type DRUG

Tacrolimus Hexal

Tacrolimus Hexal® capsules were supplied to the investigators at dose strengths of 0.5 mg,

1 mg and 1.5 mg.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

primary or sec. kidney transplanted patiens, written consent, cold ischemia \< 24 h

Exclusion:

multi organ, immunological risc pts., PRA \>20%, Antibodys against HLA-type of donor organ, hypersensitivity against Tacro or MMF,

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No