An open label, randomized pilot study evaluating the early conversion from calcineurin inhibitors to Rapamune in patients with impaired renal function following kidney transplantation - Sirolimus Switch Study

Phase 1

• Conditions: This study will be conducted in 60 established renal allograft recipients who have suffered from chronic renal failure of any cause.

• Registration Number: EUCTR2004-004884-31-GB
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2007-07-01
• Study Start: 2007-10-31
• Last Update Posted: 13 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

i.Male and female patients aged 18 to 75 years.
ii.Patients with a calculated creatinine clearance (GFR, Cockcroft & Gault method) of > 40 ml/min and < 60 ml/min.
iii.Patients with a deterioration of calculated creatinine clearance (GFR, Cockcroft & Gault method) from 3 to 9 months post renal transplantation.
iv.Patients treated with a calcineurin inhibitor, either cyclosporin or tacrolimus for a minimum of 3 months before study entry.
v.Patients between 6 – 9 months post renal transplantation.
vi.Female patients of childbearing age must have a negative serum pregnancy test and agree to use medically accepted form of contraception for the duration of the study and for 3 months following discontinuation of Rapamune.
vii.Able and willing to give written informed consent to participate in the trial and co-operate with the trial requirements
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

i.Known hypersensitivity to Rapamune and its derivatives.
ii.Evidence of active systemic or localized infection.
iii.Current use of cimetidine, terfenedine, astemizole, pimozide or azole anti-fungals (medications to be discontinued at least 24 hours before administration of sirolimus).
iv.Baseline fasting cholesterol level > 7.8 mmol/L and or triglycerides > 4.6 mmol/L.
v.Know or suspected malignancy within 5 years prior to study entry (with the exception of adequately treated basal cell or squamous cell carcinomas of the skin) or a history of PTLD.
vi.Use of any investigational drug or treatments within 30 days before study entry.
vii.Multiple organ transplants (e.g. kidney-pancreas)
viii.History of alcohol or drug abuse.
ix.Previous participation in this trial.
x.HIV positive patients
xi. Patients with proteinuria >800mg/24 hours

Study & Design

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