Protocol Calcineurin Inhibitor (CNI) Weaning

• Status: Terminated
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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®).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nantes University Hospital
• Treatments: Calcineurin Inhibitors; Tacrolimus

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.