Phase 3
Completed N=613
Non-inferiority Study of Safety and Efficacy of Everolimus With Low Dose Tacrolimus to Mycophenolate Mofetil With Standard Dose Tacrolimus in Kidney Transplant Recipients
Source: ClinicalTrials.gov NCT01025817 ↗Enrolled (actual)
613
Serious AEs
48.5%
Results posted
Jun 2014
Primary outcomePrimary: Number of Participants With Incidence of Composite Efficacy Failure — 76; 62; 59; 34 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Incidence of Composite Efficacy Failure |
76; 62; 59; 34; 4; 12 | — |
| SECONDARY Estimated Glomerular Filtration Rate (eGFR) |
63.14; 63.06 | — |
| SECONDARY Number of Participants With Incidence of CMV (Viremia, Syndrome and Disease) |
9; 13; 7; 10; 2; 8 | — |
| SECONDARY Number of Participants With Incidence Rates of BKV Viremia, BKV Viruria, or BKV Nephropathy |
19; 27; 19; 15; 5; 5 | — |
| SECONDARY Number of Participants With Incidence of New Onset of Diabetes Mellitus |
25; 22; 15; 12; 13; 14 | — |
| SECONDARY Number of Participants With Incidence of Proteinuria Events |
243; 250; 36; 35 | — |
| SECONDARY Number of Participants With Incidence of Adverse Events, Serious Adverse Events, and Tacrolimus-associated Adverse Events |
303; 302; 266; 263; 233; 247 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01025817). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.