A RANDOMISED CONTROLLED TRIAL COMPARING THE USE OF SIROLIMUS BASED BIPHASIC IMMUNOSUPRESSION WITH MYFORTIC TO ALLOW EARLY CNI WITHDRAWAL IN RENAL TRNASPLANTATION - Effects of Myfortic and Rapamycin on the Early Development of Chronic allograft Nephropathy: A Rando

Phase 1

• Conditions: Chronic Allograft Nephropathy; MedDRA version: 8.1Level: LLTClassification code 10063209Term: Chronic allograft nephropathy

• Registration Number: EUCTR2006-004773-99-GB
• Lead Sponsor: niversity Hospitals Leicester

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06-14
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients will be eligible for the trial if all of the following criteria are met:

1.Age greater than or equal to 18 years.

2.Patients receiving a primary or secondary renal allograft from a living related, living unrelated or heart-beating cadaveric donor.

3.Patients with second transplants must have maintained their primary graft for at least six months after transplantation (with the exception of graft failure due to technical reasons).

4.Stable renal allograft function over the first 3 months post transplant.

5.An absence of subclinical rejection on the 3 month protocol biopsy.

6.Signed written informed consent.

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

Exclusion Criteria

Patients will not be eligible for the trial if any of the following criteria apply:

1.Kidney transplantation from a non heart-beating donor.

2.Patients suffering an acute rejection episode in the first 3 months post transplant with a Banff classification of 1b or above.

3.Sub-clinical rejection seen in the 3 month protocol biopsy.

4.Proteinuria >500mg/24hours

5.eGFR <40mls/min (Cockcroft-Gault formula).

6.Evidence of active systemic or localised major infection at study entry.

7.Known hypersensitivity to Tacrolimus, macrolide antibiotics or Myfortic.

8.Use of any investigational drug or treatments within 28 days before study entry.

9.Known or suspected malignancy within five years before study entry.

10.Any condition which in the opinion of the investigator makes the patient unsuitable for entry into the study.

Study & Design

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