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OpenTrials
Completed

NCT Number: NCT00154284

Everolimus in a Cyclosporine Microemulsion-free Regimen Compared to a Low-dose Cyclosporine Microemulsion Regimen, in de Novo Kidney Transplant Patients

The purpose of this study is to evaluate the safety and efficacy of everolimus in combination with basiliximab, and steroids with and without cyclosporine microemulsion in de novo kidney transplant recipients.

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Key information

Conditions

Organ Transplantation, Renal Transplantation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

This is a combined analysis using 81 patients randomized and treated in CRAD001A2419 (NCT00154284) with 33 randomized and treated in CRAD001A2423 (NCT00170807). This approach is reflected in the protocol amendments for each study, and the one clinical study report for both.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Recipients of a first renal transplant from a primary cadaveric or non-HLA identical living related donor.
  • Renal cold ischemic time < 36 hours.
  • Age of donor < 65 years.

Exclusion criteria

  • Patients who have received an investigational drug within 4 weeks of baseline period.
  • Patients who are recipients of multiple organ transplants, including any organ other than kidney.
  • Recipients of non-heart beating donor organs.

Other protocol-defined exclusion criteria may apply.

Treatment and study plan

Everolimus (Certican)

Drug

Other names: Certican

Cyclosporine (Neoral)

Drug

Other names: Neoral

Steroid

Drug

Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.

Other names: Prednisone

Basiliximab (Simulect)

Drug

Other names: Simulect

Primary outcomes

  1. Renal Function Measured by Calculated Glomerular Filtration Rate (GFR Calculated According to the Nankivell Formula)

    Time frame: At Month 3 and Month 12

    Nankivell's formula for calculated GFR is shown below:

    GFR [mL/min] = 6.7/C + W/4 - UREA/2 - 100/H2+ 35 (25 for females). Where W is body weight at specific visit [kg], H is height at specific visit [m], C is the serum concentration of creatinine [mmol/L], and UREA is the serum concentration of urea [mmol/L]. UREA was calculated from blood urea nitrogen (BUN) lab data by: UREA = 2.1441*BUN. If a GFR value from Nankivell formula was less than 10 [mL/min], then the value was assigned as 10 [mL/min].

Secondary outcomes

  1. Number of Participants With Biopsy-proven Acute Rejection (BPAR) Episodes, Graft Loss, Death or Loss to Follow-up

    Time frame: Month 12

    Renal biopsies were collected for all cases of suspected acute rejection. For these cases, regardless of initiation of anti-rejection treatment, a graft core biopsy had been performed within 48 hours. These biopsies were listed on the Kidney Allograft Biopsy eCRF and the results used for patient management for BPAR. Graft loss was defined as the allograft was presumed to be lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis as well as re-transplant. BPAR, graft loss, death, or loss to follow-up was analyzed by means of frequency tables.

  2. Serum Creatinine at Month 6 and 12

    Time frame: 6 month and 12 months

    serum creatinine summarized by mean and standard deviation

  3. Calculated Creatinine Clearance at 6 Month and 12 Month

    Time frame: 6 month and 12 months

    Creatinine clearance calculated by Cockcroft-Gault formula and summarized by mean, and standard deviation. Cockcroft-Gault formula to calculate Creatinine Clearance (CrCl[mL/min]) is shown below:

    CrCl[mL/min] = (140 - A) * W / (72 * C) * R. Where A is age at sample date [years], W is body weight at specific visit [kg], C is the serum concentration of creatinine [mg/dL], R = 1 if the patient is male and = 0.85 if female.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A 12 Month, Multicenter, Randomized, Parallel, Open-label Study, to Evaluate Renal Function and Efficacy of Everolimus With Basiliximab and Cyclosporine Microemulsion Discontinuation at 3 Month Post-transplant Versus Minimization, in de Novo Kidney Transplant Recipients

Acronym: CERTES02

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Sep 12, 2005
Registry last updated
Aug 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.