Optimized TacrolimuS and MMF for HLA Antibodies (proteins that are sometimes produced by the immune system) after Renal Transplantatio

• Conditions: Renal Transplant recipients with HLA antibodies, who are at increased risk of graft dysfunction and graft failure; MedDRA version: 14.1Level: LLTClassification code 10050436Term: Prophylaxis against renal transplant rejectionSystem Organ Class: 100000004865; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2012-004308-36-GB
• Lead Sponsor: Kings College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-10
• Last Update Posted: 4 February 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Written and witnessed informed consent to participate.
• Renal transplant recipients >1 year post-transplantation, male or female
• Aged 18-70 years
• Estimated glomerular filtration rate (eGFR by 4 variable MDRD) of =30.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 3000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3000

Exclusion Criteria

• Recipient requiring HLA desensitisation to remove antibody for a positive XM transplant
• Recipient known already to have HLA antibody WHO HAS RECEIVED specific intervention for that antibody or for CAMR / chronic rejection
• Recipient of additional solid organ transplants (e.g. pancreas, heart, etc).
• History of malignancy in previous 5 years (excluding non-melanomatous tumours limited to skin)
• HBsAg+,HBcAb+, HepC+ or HIV+ recipient (on test performed within previous 5 years)
• History of acute rejection requiring escalation of immunosuppression in the 6 months prior to screening.
• Patient enrolled in any other studies involving administration of another IMP at time of recruitment
The following exclusion criteria are based on information contained within the SMPcs of the IMPs
• History of an ongoing or previous infection (no time limit) that would prevent optimization of immunosuppression, including ocular Herpes simplex.
• Known hypersensitivity to any of the IMPs
• Known hereditary disorders of carbohydrate metabolism
• Pregnancy or breastfeeding females (based on verbal history of recipient)
• Pre-menopausal females who refuse to consent to using suitable methods of contraception throughout the trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified