A prospective, open, randomized, single center study comparing the effects of duo therapy with Everolimus and steroids versus triple treatment of low dose calcineurin inhibitor, low-dose MMF and steroids at least one year after renal transplantation. Effects on renal function, tolerability, chronic allograft damage, cardiovascular parameters and malignancies.

Phase 4

Completed

Conditions: acute rejection
renal function
10038430

Registration Number: NL-OMON35450

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 130

Inclusion Criteria

• Female or male, aged between 18 and 70 years.
• Recipient of a kidney graft from a deceased donor or living (non-HLA identical) donor.
• The patient understands the purpose and risks of the study and has given written informed consent to participate in the study.
• Acceptable renal function, eGFR > 40 ml/min, Proteinuria <= 1, 0 g/24hr.

Exclusion Criteria

• Patients with multi-organ transplants.
• Patients who have been receiving a second or subsequent transplant.
• Patients with very low function at 1 year post-transplant, GFR < 40.
• Proteinuria > 1, 0 g/24 hr.
• Patients with a screening/baseline total white blood cell count < 2,0 10Eg/l or ANC < 1,0 10Eg/l, platelet count < 100 10Eg/l.
• Patients with baseline fasting triglycerides > 4.5 mmol/l or fasting total cholesterol > 7.8 mmol/l despite optimal lipid-lowering therapy.
• Presence of sub clinical rejection (Borderline or Banff score >1a) in biopsy taken at approximately month 12
• Vascular or Acute rejection (Banff score >= 2a) six months preceding randomization.
• Female patients who are pregnant or unwilling to use adequate contraception during the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoints: Renal function. The percentage of patients that need<br /><br>reconversion to their original therapy. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints: Cardiovascular incidents and PWV/ AGES, Blood pressure and<br /><br>the number of antihypertensives. The incidence of malignancies, the incidence<br /><br>of infections, Haematological and Lipid parameters, Proteinuria.</p><br>