A twelve-month, multicenter, open-label, randomized study of the safety, tolerability and efficacy of Certican* with Simulect, corticosteroids and two different exposure levels of tacrolimus in de novo renal transplant recipients

A twelve-month, multicenter, open-label, randomized study of the safety, tolerability and efficacy of Certican* with Simulect, corticosteroids and two different exposure levels of tacrolimus in de novo renal transplant recipients - NA

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON30348

Enrollment

Registered

2006-06-06

Start date

2006-06-27

Completion date

Unknown

Last updated

2024-08-12

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

Conditions

transplantatie geneeskunde renal transplantation

Interventions

At month 3, the tacrolimus dosage in the study arm (A) is lowered.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Male or female 18-65 years old Primary transplant from cadaveric, living-unrelated or non-HLA identical living related donor Cold Ischemia time

Exclusion criteria

Exclusion criteria: Multiple organtransplants Non-heart beating donor PRA>=50% Hypercholestrolemia >9,1 mmol/L Leucocytes

Design outcomes

Primary

Measure	Time frame
This objective will be assessed by comparing renal function evaluated by calculated glomerular filtration rate (MDRD formula) at 12 months post-transplant (this method has gained favor in the transplant literature above the endogenous creatinine clearance because its reproducibility is far greater).	—

Secondary

Measure	Time frame
The main secondary objective is to assess efficacy of the two regimens. This will be evaluated by the comparison between the two groups of the incidence of biopsy-proven acute rejection (BPAR) from Month 4 until Month 12 after transplantation The other secondary objectives are to assess the efficacy and safety of the two regimens. This will be evaluated at 12 months by the comparison between the two groups of: Incidence of efficacy failure defined as biopsy-proven acute rejection (BPAR), graft loss, death or lost to follow-up Incidence of each of the components of efficacy failure Incidence of treated acute rejection Renal function as measured by serum creatinine value and creatinine clearance (Cockcroft-Gault formula) Change in renal function evaluated by calculated GFR (MDRD formula) and creatinine clearance (Cockcroft-Gault formula) between Months 4 and 12 Incidence of SAEs Incidence of AEs Incidence of new onset diabetes mellitus defined as fasting plasma glucose >= 126 mg/dL or symptoms of diabetes plus casual plasma glucose >= 200 mg/dL or 2h plasma glucose >= 200 mg/dL during an Oral Glucose Tolerance Test (OGTT)	—

Measure

Time frame

The main secondary objective is to assess efficacy of the two regimens. This will be evaluated by the comparison between the two groups of the incidence of biopsy-proven acute rejection (BPAR) from Month 4 until Month 12 after transplantation The other secondary objectives are to assess the efficacy and safety of the two regimens. This will be evaluated at 12 months by the comparison between the two groups of: Incidence of efficacy failure defined as biopsy-proven acute rejection (BPAR), graft loss, death or lost to follow-up Incidence of each of the components of efficacy failure Incidence of treated acute rejection Renal function as measured by serum creatinine value and creatinine clearance (Cockcroft-Gault formula) Change in renal function evaluated by calculated GFR (MDRD formula) and creatinine clearance (Cockcroft-Gault formula) between Months 4 and 12 Incidence of SAEs Incidence of AEs Incidence of new onset diabetes mellitus defined as fasting plasma glucose >= 126 mg/dL or symptoms of diabetes plus casual plasma glucose >= 200 mg/dL or 2h plasma glucose >= 200 mg/dL during an Oral Glucose Tolerance Test (OGTT)

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)