Protocol Calcineurin Inhibitor (CNI) Weaning

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

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2015-05-31

Brief Summary

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The main objective of this study is to demonstrate the benefit of the withdrawal of Tacrolimus (Prograf®) on renal function in patients one year after the end of the weaning period. The secondary objectives will focus on assessing the risks and consequences of withdrawal of Tacrolimus (Prograf®).

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Detailed Description

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Conditions

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Function of Renal Transplant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Tacrolimus

Group Type ACTIVE_COMPARATOR

Tacrolimus

Intervention Type DRUG

A control group continued conventional therapy, Tacrolimus (Prograf®) ("control" group) and will be followed in parallel group "withdrawal" that will stop treatment with Tacrolimus (Prograf®).

Withdrawal of Tacrolimus

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Patients randomized to the "withdrawal"group will begin the protocol with their usual dose of Tacrolimus (Prograf®) (initial dose). The initial dose of tacrolimus (Prograf®) will be reduced by one third at visit 3 (day 0) and again a third visit 5 (J60). The complete withdrawal Tacrolimus (Prograf®) begins to visit 7 (J120). The withdrawal of Tacrolimus (Prograf®) will be obtained in four months. Monitoring of all patients lasted 17 months in total from the screening visit, which corresponds to 12 months after complete withdrawal of Tacrolimus (Prograf®) for patients in the "withdrawal" group.

Interventions

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Tacrolimus

A control group continued conventional therapy, Tacrolimus (Prograf®) ("control" group) and will be followed in parallel group "withdrawal" that will stop treatment with Tacrolimus (Prograf®).

Intervention Type DRUG

Placebo

Patients randomized to the "withdrawal"group will begin the protocol with their usual dose of Tacrolimus (Prograf®) (initial dose). The initial dose of tacrolimus (Prograf®) will be reduced by one third at visit 3 (day 0) and again a third visit 5 (J60). The complete withdrawal Tacrolimus (Prograf®) begins to visit 7 (J120). The withdrawal of Tacrolimus (Prograf®) will be obtained in four months. Monitoring of all patients lasted 17 months in total from the screening visit, which corresponds to 12 months after complete withdrawal of Tacrolimus (Prograf®) for patients in the "withdrawal" group.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female aged between 18 and 80 years (inclusive),
* Having received a deceased donor transplant or living with ABO compatibility,
* First renal allograft for at least 4 years and under 10 years,
* Presenting a stable renal function : serum creatinine with a variation of ± 25% of the average of the year before inclusion,
* Treated with tacrolimus (Prograf®) in combination with MPA (Cellcept® and Myfortic®) + / - steroids (between 5 and 10 mg per day),
* Patient has given informed consent,
* Patient insured,
* Patient (of childbearing age) with effective contraception.

* Glomerular Filtration Rate (GFR), defined by the dosage of cystatin C ≥ 40 ml/min/1, 73m²,
* Proteinuria ≤ 0,5 g / day,
* Patient with serum levels of Tacrolimus between 5 to 10 ng / ml on average during the last 6 months (inclusive). It is accepted that 25% of the assays performed during the last 6 months, serum levels of tacrolimus are outside the limits mentioned above (5-10 ng / ml). They must nevertheless be between 3.5 to 12.5 ng / ml (inclusive).
* Patient with serum levels of MPA (Cellcept® and Myfortic®) higher ≥ 30 mg / ml,
* No anti-HLA antibodies at the time of inclusion, verified using highly sensitive techniques (Luminex HD),
* Lack of histological evidence of cellular or humoral acute or chronic or subclinical rejection on renal graft according to the latest classification of Banff 2009.

Exclusion Criteria

* Patients under age 18 or over 80 years,
* Transplanted from less than 4 years and over 10 years,
* Patients re-transplanted,
* Transplantation of several organs,
* Patient not treated with tacrolimus as maintenance therapy,
* Serum levels of Tacrolimus patient \<5 or \>10 ng / ml,
* Serum levels of MPA of the patient \<30 mg / ml,
* Patients treated with other immunosuppressive drugs that Tacrolimus (Prograf®), MPA (Cellcept® and Myfortic®) and steroids,
* Patient not having a stable graft function at baseline (change in serum creatinine \> 25% of the average of the year before inclusion in the study), with a GFR defined by the dosage of cystatin C \<40 ml/min/1, 73m² at the time of inclusion,- Patients with proteinuria \> 0.5 g at study entry,
* Patient with HLA antibodies at study entry,
* Patient non-compliant,
* Presence of histological evidence of cellular or humoral acute or chronic or subclinical rejection on renal graft according to the latest classification of Banff 2009,
* History of lymphoproliferative disorders,
* Diagnosis of a malignancy within 5 years before enrollment,
* Significantly abnormal hematologic data of a clinical standpoint, as determined by the investigator for hematocrit, hemoglobin, white blood cell count or platelets,
* Data significantly abnormal blood biochemistry of a clinical standpoint, as determined by the investigator,
* Abuse of significant drug or alcohol at the time of inclusion, determined by the investigator,
* Patient positive for antibodies to hepatitis C or hepatitis B surface antigen of hepatitis B (HBsAg) or HIV infection,
* Participation in a clinical study within 3 months,
* Pregnancy, Breastfeeding.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No