Individually Adapted Immunosuppression in de Novo Renal Transplantation Based on Immune Function Monitoring: a Prospective Randomised Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2016-10-31

Brief Summary

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This study is an open, randomised trial in which one group of patients (control) will receive the golden standard therapy and the other group (treatment) will receive individually adapted immunosuppression.

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Detailed Description

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Conditions

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Kidney Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

individual adapted immunosuppression

Group Type EXPERIMENTAL

individual adapted immunosuppression

Intervention Type DRUG

individual adapted immunosuppression

2

golden standard therapy

Group Type ACTIVE_COMPARATOR

golden standard therapy

Intervention Type DRUG

golden standard therapy

Interventions

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individual adapted immunosuppression

Intervention Type DRUG

golden standard therapy

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* First or second kidney transplantation
* Males and females, 18 years old or older
* Women of childbearing potential must have a negative serum or urine pregnancy test with sensitivity equal to at least 50 mIU/mL
* Patients must be capable of understanding the purpose and risks of the study and must sign an informed consent form

Exclusion Criteria

* Multiple organ transplantation (eg. kidney-pancreas, kidney-heart, kidney-liver,...)
* Transplantation of a patient who received another organ transplant previously except one kidney transplant
* Recipients of HLA-identical living-related renal transplants
* Patients with PRA \> 10%, patients who have lost a first graft from rejection.
* Pregnant or lactating women
* WBC =\< 2.5 x 109/L (IU), platelet count =\< 100 x 109/L (IU), or Hb =\< 6g/dl at the time of entry into the study
* Active peptic ulcer
* Severe diarrhea or other gastrointestinal disorders which might interfere with the ability to absorb oral medication, including diabetic patients with previously diagnosed diabetic gastroenteropathy
* Known HIV-1 or HTLV-1 positive tests
* History of malignancy in the past 5 years (with the exception of adequately treated basal or squamous skin cell carcinoma)
* The use of investigational drugs or other immunosuppressive drugs as those specified in this protocol
* Patients receiving bile acid sequestrants
* Psychological illness or condition interfering with the patient's compliance or ability to understand the requirements of the study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No