Trial · 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

NCT01025817, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2014-06-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Non-inferiority Study of Safety and Efficacy of Everolimus With Low Dose Tacrolimus to Mycophenolate Mofetil With Standard Dose Tacrolimus in Kidney Transplant Recipients. Trials, record NCT01025817. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01025817

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Non-inferiority Study of Safety and Efficacy of Everolimus With Low Dose Tacrolimus to Mycophenolate Mofetil With Standard Dose Tacrolimus in Kidney Transplant Recipients
NCT number: NCT01025817
Status: Completed
Phases: Phase 3
Enrollment: 613 participants, actual
Lead sponsor: Novartis Pharmaceuticals
Conditions: Kidney Transplant
Interventions: Everolimus and tacrolimus, mycophenolate mofetil and tacrolimus
First posted: 2009-12-04
Last updated: 2015-11-11
Results first posted: 2014-06-06
Limitations and caveats: HLA mismatches ≥3, everolimus group 261 vs MMF group 240

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Incidence of Composite Efficacy Failure	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	Estimated Glomerular Filtration Rate (eGFR)	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
Secondary	Number of Participants With Incidence of CMV (Viremia, Syndrome and Disease)	12 Months	Participants with incidence of CMV (viremia, syndrome and disease). CMV is cytomegalovirus.
Secondary	Number of Participants With Incidence Rates of BKV Viremia, BKV Viruria, or BKV Nephropathy	12 Months	Participants with Incidence of BKV (viremia, viruria, or nephropathy). BKV is Polyomavirus type BK.
Secondary	Number of Participants With Incidence of New Onset of Diabetes Mellitus	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)
Secondary	Number of Participants With Incidence of Proteinuria Events	Baseline and 12 Months	Number of participants with Incidence of proteinuria events indicating chronic kidney disease
Secondary	Number of Participants With Incidence of Adverse Events, Serious Adverse Events, and Tacrolimus-associated Adverse Events	12 Months	Incidence of adverse events, serious adverse events, and tacrolimus-associated adverse events by System Organ Class

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Incidence of Composite Efficacy Failure	12 Months	Full Analysis Set (FAS) consisted of all participants randomized after transplantation	Participants	NUMBER
SECONDARY	Estimated Glomerular Filtration Rate (eGFR)	12 Months	Full Analysis Set (FAS) consisted of all patients randomized after transplantation	mL/min/1.73m˄2	MEAN
SECONDARY	Number of Participants With Incidence of CMV (Viremia, Syndrome and Disease)	12 Months	Safety Set (SS) consisted of all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment. The statement that a patient had no adverse events constitutes a safety assessment. Those who received at least 1 dose of drug but had no post-treatment safety data of any kind are excluded from SS.	Participants	NUMBER
SECONDARY	Number of Participants With Incidence Rates of BKV Viremia, BKV Viruria, or BKV Nephropathy	12 Months	Safety Set (SS) consisted of all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment. The statement that a patient had no adverse events constitutes a safety assessment. Those who received at least 1 dose of drug but had no post-treatment safety data of any kind are excluded from SS	Participants	NUMBER
SECONDARY	Number of Participants With Incidence of New Onset of Diabetes Mellitus	12 Months	Safety Set (SS) consisted of all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment. The statement that a patient had no adverse events constitutes a safety assessment. Those who received at least 1 dose of drug but had no post-treatment safety data of any kind are excluded from SS.	Participants	NUMBER
SECONDARY	Number of Participants With Incidence of Proteinuria Events	Baseline and 12 Months	Safety Set (SS) consisted of all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment. The statement that a patient had no adverse events constitutes a safety assessment. Those who received at least 1 dose of drug but had no post-treatment safety data of any kind are excluded from SS	Participants	NUMBER
SECONDARY	Number of Participants With Incidence of Adverse Events, Serious Adverse Events, and Tacrolimus-associated Adverse Events	12 Months	Safety Set (SS) consisted of all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment. The statement that a patient had no adverse events constitutes a safety assessment. Those who received at least 1 dose of drug but had no post-treatment safety data of any kind are excluded from SS	Participants	NUMBER

Source ClinicalTrials.gov

Results by group86

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Number of Participants With Incidence of Composite Efficacy Failure	Everolimus and Low Dose Tacrolimus	Composite Endpoint	76	Participants
Number of Participants With Incidence of Composite Efficacy Failure	Mycophenolate Mofetil and Standard Dose Tacrolimus	Composite Endpoint	62	Participants
Number of Participants With Incidence of Composite Efficacy Failure	Everolimus and Low Dose Tacrolimus	Treated Biopsy-proven Acute rejection (BPAR)	59	Participants
Number of Participants With Incidence of Composite Efficacy Failure	Mycophenolate Mofetil and Standard Dose Tacrolimus	Treated Biopsy-proven Acute rejection (BPAR)	34	Participants
Number of Participants With Incidence of Composite Efficacy Failure	Everolimus and Low Dose Tacrolimus	Graft Loss	4	Participants
Number of Participants With Incidence of Composite Efficacy Failure	Mycophenolate Mofetil and Standard Dose Tacrolimus	Graft Loss	12	Participants
Number of Participants With Incidence of Composite Efficacy Failure	Everolimus and Low Dose Tacrolimus	Death	6	Participants
Number of Participants With Incidence of Composite Efficacy Failure	Mycophenolate Mofetil and Standard Dose Tacrolimus	Death	5	Participants
Number of Participants With Incidence of Composite Efficacy Failure	Everolimus and Low Dose Tacrolimus	Loss to follow up	9	Participants
Number of Participants With Incidence of Composite Efficacy Failure	Mycophenolate Mofetil and Standard Dose Tacrolimus	Loss to follow up	17	Participants

1 to 10 of 86Source ClinicalTrials.gov

See all 86 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Completed Study Medication	STARTED	Everolimus and Low Dose Tacrolimus	309
Completed Study Medication	STARTED	Mycophenolate Mofetil and Standard Dose Tacrolimus	304
Completed Study Medication	COMPLETED	Everolimus and Low Dose Tacrolimus	204
Completed Study Medication	COMPLETED	Mycophenolate Mofetil and Standard Dose Tacrolimus	232
Completed Study Medication	NOT COMPLETED	Everolimus and Low Dose Tacrolimus	105
Completed Study Medication	NOT COMPLETED	Mycophenolate Mofetil and Standard Dose Tacrolimus	72
Completed Study	STARTED	Everolimus and Low Dose Tacrolimus	309
Completed Study	STARTED	Mycophenolate Mofetil and Standard Dose Tacrolimus	304
Completed Study	COMPLETED	Everolimus and Low Dose Tacrolimus	293
Completed Study	COMPLETED	Mycophenolate Mofetil and Standard Dose Tacrolimus	282

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events742

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anaemia	Blood and lymphatic system disorders	Everolimus and Low Dose Tacrolimus	83	306
other	Anaemia	Blood and lymphatic system disorders	Mycophenolate Mofetil and Standard Dose Tacrolimus	67	304
other	Leukocytosis	Blood and lymphatic system disorders	Everolimus and Low Dose Tacrolimus	22	306
other	Leukocytosis	Blood and lymphatic system disorders	Mycophenolate Mofetil and Standard Dose Tacrolimus	31	304
other	Leukopenia	Blood and lymphatic system disorders	Everolimus and Low Dose Tacrolimus	27	306
other	Leukopenia	Blood and lymphatic system disorders	Mycophenolate Mofetil and Standard Dose Tacrolimus	65	304
other	Neutropenia	Blood and lymphatic system disorders	Everolimus and Low Dose Tacrolimus	7	306
other	Neutropenia	Blood and lymphatic system disorders	Mycophenolate Mofetil and Standard Dose Tacrolimus	24	304
other	Thrombocytopenia	Blood and lymphatic system disorders	Everolimus and Low Dose Tacrolimus	22	306
other	Thrombocytopenia	Blood and lymphatic system disorders	Mycophenolate Mofetil and Standard Dose Tacrolimus	16	304

1 to 10 of 742Source ClinicalTrials.gov

See all 742 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Everolimus and Low Dose Tacrolimus
Total, all-cause mortality	Mycophenolate Mofetil and Standard Dose Tacrolimus
Total, other adverse events	Everolimus and Low Dose Tacrolimus	302	306
Total, other adverse events	Mycophenolate Mofetil and Standard Dose Tacrolimus	299	304
Total, serious adverse events	Everolimus and Low Dose Tacrolimus	154	306
Total, serious adverse events	Mycophenolate Mofetil and Standard Dose Tacrolimus	142	304

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
28141897	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Everolimus and Low Dose Tacrolimus vs Mycophenolate Mofetil and Standard Dose Tacrolimus: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01025817

GET https://conductscience.org/api/trials/v1/NCT01025817/results?page=2

API reference For AI assistants