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. - STER

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-014436-38-NL

Enrollment

130

Registered

2009-07-13

Start date

2009-09-25

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal transplantation.

Interventions

Trade Name: Certican Product Name: Certican Pharmaceutical Form: Tablet Trade Name: Neoral Product Name: Neoral Pharmaceutical Form: Capsule* Trade Name: Prograft Product Name: Prograft Pharmaceutic

Eligibility

Sex/Gender

All

Inclusion criteria

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. 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

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 1, 0 g/24 hr. • Patients with a screening/baseline total white blood cell count 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.

Design outcomes

Primary

Measure	Time frame
Secondary Objective: ;Primary end point(s): • Renal function • The percentage of patients that need reconversion to their original therapy (tolerability). ;Main Objective: To investigate the safety and efficacy of a therapy consisting Everolimus and corticosteroids maintenance immunosuppressive regime twelve months after renal transplantation in recipients of donor kidney graft on graft function and acute rejection rates. The other group will receive a low-dose regimen consisting a low-dose calcineurin inhibitor, low dose MMF and corticosteroids.	—

Measure

Time frame

Secondary Objective: ;Primary end point(s): • Renal function • The percentage of patients that need reconversion to their original therapy (tolerability). ;Main Objective: To investigate the safety and efficacy of a therapy consisting Everolimus and corticosteroids maintenance immunosuppressive regime twelve months after renal transplantation in recipients of donor kidney graft on graft function and acute rejection rates. The other group will receive a low-dose regimen consisting a low-dose calcineurin inhibitor, low dose MMF and corticosteroids.

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Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026