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Completed

NCT Number: NCT01025817

Non-inferiority Study of Safety and Efficacy of Everolimus With Low Dose Tacrolimus to Mycophenolate Mofetil With Standard Dose Tacrolimus in Kidney Transplant Recipients

The purpose of this phase 3b study is to compare the safety and efficacy of everolimus with low dose tacrolimus to mycophenolate mofetil with standard dose tacrolimus in kidney transplant recipients.

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Key information

Conditions

Kidney Transplant

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Montreal, Quebec, Canada

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female renal recipients 18-70 years of age undergoing kidney transplantation, either primary or re-transplant;
  • Recipient of a cadaveric, deceased donor (including expanded criteria donor organs and deceased donor organs after cardiac death), living unrelated or non-HLA identical living related donor kidney;
  • Graft must be functional (producing greater than or equal to 100 ml of urine within 24 hours after transplantation) at time of randomization.

Exclusion criteria

  • Donor organ with a cold ischemic time > 30 hours;
  • Males or females who produce less than 100 ml of urine in the first 24 hours post-transplantation;
  • Males or females who are recipients of ABO incompatible transplants, or T cell, or B cell crossmatch positive transplant;
  • Males or females with severe total hypercholesterolemia or total hypertriglyceridemia (Patients on lipid lowering treatment with controlled hyperlipidemia are acceptable);
  • Males or females who have any surgical or any medical condition, such as severe diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus, which in the opinion of the investigator, might alter the absorption, distribution, metabolism and/or excretion of study medication.

Other protocol related inclusion/exclusion criteria may apply.

Treatment and study plan

Everolimus and tacrolimus

Drug

Everolimus:

  • Dosage form: 0.75 mg, 0.25 mg, and 0.5 mg tablets
  • Dose: 1.5 mg per day
  • Frequency: 0.75 mg twice daily

Tacrolimus:

  • Dose adjusted to maintain specific blood levels

mycophenolate mofetil and tacrolimus

Drug

Mycophenolate mofetil: - Dose form: 250 mg capsule - Dose: 2g per day - Frequency: 1g twice daily Tacrolimus: - Dose adjusted to maintain specific blood levels

Other names: Active Comparator Control)

Primary outcomes

  1. Number of Participants With Incidence of Composite Efficacy Failure

    Time frame: 12 Months

    Efficacy failure rate used the composite endpoint of: (1) treated biopsy-proven acute rejection (BPAR)*, (2) graft loss**, (3) participant death or(4) loss to follow-up. *A treated BPAR was defined as a biopsy graded IA, IB, IIA, IIB, or III and which was treated with anti-rejection therapy. **Graft loss is defined as when the allograft was presumed lost on the day the participant started dialysis and was not able to subsequently be removed from dialysis.

Secondary outcomes

  1. Estimated Glomerular Filtration Rate (eGFR)

    Time frame: 12 Months

    Renal function was assessed by estimated Glomerular Filtration Rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) formula. MDRD formula: GFR [mL/min/1.73m˄2] = 186.3*(C˄-1.154)*(A˄-0.203)*G*R. DEFINITIONS: C = serum concentration of creatinine [mg/dL]; A = age [years]; G = 0.742 when gender is female, otherwise G = 1; R = 1.21 when race is black, otherwise R = 1

  2. Number of Participants With Incidence of CMV (Viremia, Syndrome and Disease)

    Time frame: 12 Months

    Participants with incidence of CMV (viremia, syndrome and disease). CMV is cytomegalovirus.

  3. Number of Participants With Incidence Rates of BKV Viremia, BKV Viruria, or BKV Nephropathy

    Time frame: 12 Months

    Participants with Incidence of BKV (viremia, viruria, or nephropathy). BKV is Polyomavirus type BK.

  4. Number of Participants With Incidence of New Onset of Diabetes Mellitus

    Time frame: 12 Months

    Incidence of new onset diabetes mellitus defined as non-diabetic patients before transplantation, who are receiving glucose lowering treatment for more than 30 days post-transplant, or with a random plasma glucose ≥200 mg dL (11.1 mmol/L) with 2 fasting plasma glucose values ≥126 mg/dL (7 mmol/L)

  5. Number of Participants With Incidence of Proteinuria Events

    Time frame: Baseline and 12 Months

    Number of participants with Incidence of proteinuria events indicating chronic kidney disease

  6. Number of Participants With Incidence of Adverse Events, Serious Adverse Events, and Tacrolimus-associated Adverse Events

    Time frame: 12 Months

    Incidence of adverse events, serious adverse events, and tacrolimus-associated adverse events by System Organ Class

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A 12 Month, Multi-center, Randomized, Open-label Non-inferiority Study Comparing Safety and Efficacy of Concentration-controlled Everolimus With Low Dose Tacrolimus to Mycophenolate Mofetil With Standard Dose Tacrolimus in de Novo Renal Transplant Recipients

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Dec 4, 2009
Registry last updated
Nov 11, 2015

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.

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