Protocol Calcineurin Inhibitor (CNI) Weaning

Nantes University Hospital (NUH)

Status and phase

Terminated

Phase 3

Conditions

Function of Renal Transplant

Treatments

Drug: Tacrolimus

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01292525

2010-019574-33 (EudraCT Number)

09/7-D

Details and patient eligibility

About

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®).

Enrollment

16 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Pre-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.

Inclusion Criteria:

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.