Trial · NCT00862979

A Study Investigating the Renal Tolerability, Efficacy, and Safety of a CNI-free Versus a Standard Regimen in de Novo Heart Transplant (HTx) Recipients

NCT00862979, Phase 4, Completed, Novartis Pharmaceuticals; results first posted 2018-06-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study Investigating the Renal Tolerability, Efficacy, and Safety of a CNI-free Versus a Standard Regimen in de Novo Heart Transplant (HTx) Recipients. Trials, record NCT00862979. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00862979

On this page

Trial

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

Title: A Study Investigating the Renal Tolerability, Efficacy, and Safety of a CNI-free Versus a Standard Regimen in de Novo Heart Transplant (HTx) Recipients
NCT number: NCT00862979
Status: Completed
Phases: Phase 4
Enrollment: 162 participants, actual
Lead sponsor: Novartis Pharmaceuticals
Conditions: Heart Transplantation
Interventions: Everolimus (EVR), cyclosporine A (CyA), tacrolimus (TAC), Enteric coated mycophenolate sodium (EC-MPS), mycophenolate mofetil (MMF), Corticosteroids
First posted: 2009-03-17
Last updated: 2018-08-07
Results first posted: 2018-06-25

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame	Description
Primary	Calculated Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula at Month 18	Month 18	Calculated Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula at Month 18 cGFR (in mL/min/1.73 m2) = 186.3\(C-1.154)\(A-0.203)\G\R where C = the 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	Occurrence of Treatment Failures From Month 6 to 9 and Month 9 to 18	Month 6 to Month 9; Month 9 to Month 18	Treatment failure was defined as composite endpoint of biopsy proven acute rejection of ISHLT 1990 grade ≥ 3A resp. ISHLT 2004 grade ≥ 2R, acute rejection episodes associated with hemodynamic compromise, graft loss / re-transplant, death, loss to follow up (at least one condition must be present). If participant had an occurrence in each period it was counted for each period.
Secondary	Occurrence of Major Cardiac Events (MACE) From Month 6 to 18	Month 6 to Month 18	Major cardiac events (MACE) was defined as one of the following: any death, myocardial infarction, coronary artery bypass grafting
Secondary	Calculated Glomerular Filtration Rate (cGFR) According to Cockcroft-Gault at Month 12 and 18	Month 12 and 18	Calculated Glomerular Filtration Rate (cGFR) according to Cockcroft-Gault at Month 12 and 18. For men: GFR=(140-Age) x Body weight (kg) / 72 x Serum Creatinine (mg/dl) For women: GFR=0.85 (140 -Age) x Body weight(kg)/ 72 x Serum Creatinine (mg/dl)
Secondary	Serum Creatinine at Month 6, 8, 9, 10 12 and 18	Month 6, 8, 9, 10 12 and 18	Serum Creatinine is an indicator of renal function measured in the blood
Secondary	Reciprocal Creatinine Slope Between Month 6 and Month 18	Between Month 6 and Month 18	Reciprocal Creatinine Slope is an indication of renal function over time with a higher slope value indicating an improvement in renal function.

Source ClinicalTrials.gov

Outcomes6

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Calculated Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula at Month 18	Month 18	Full Analysis Set-Last observation carried forward (FAS-LOCF)- 145 patients were treated with study medication and had at least 1 post-baseline assessment of the primary outcome variable but for this analysis only participants that had values at Month 18 were analyzed	mL/min	MEAN
SECONDARY	Occurrence of Treatment Failures From Month 6 to 9 and Month 9 to 18	Month 6 to Month 9; Month 9 to Month 18	Full Analysis Set FAS- 145 patients were treated with study medication and had at least 1 post-baseline assessment of the primary outcome variable	Occurences	NUMBER
SECONDARY	Occurrence of Major Cardiac Events (MACE) From Month 6 to 18	Month 6 to Month 18	Full Analysis Set FAS- 145 patients were treated with study medication and had at least 1 post-baseline assessment of the primary outcome variable	Occurences	NUMBER
SECONDARY	Calculated Glomerular Filtration Rate (cGFR) According to Cockcroft-Gault at Month 12 and 18	Month 12 and 18	Full Analysis Set-Last observation carried forward (FAS-LOCF)- 145 patients were treated with study medication and had at least 1 post-baseline assessment of the primary outcome variable but for this analysis only participants that had values at Month 12 \& 18 were analyzed	mL/min	MEAN
SECONDARY	Serum Creatinine at Month 6, 8, 9, 10 12 and 18	Month 6, 8, 9, 10 12 and 18	Full Analysis Set FAS- 145 patients were treated with study medication and had at least 1 post-baseline assessment of the primary outcome variable	μmol/L	MEAN
SECONDARY	Reciprocal Creatinine Slope Between Month 6 and Month 18	Between Month 6 and Month 18	Full Analysis Set FAS- 145 patients were treated with study medication and had at least 1 post-baseline assessment of the primary outcome variable	1/(μmol/L)/(hour)	MEAN

Source ClinicalTrials.gov

Results by group28

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

Outcome	Group	Category	Value	Spread	Units
Calculated Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula at Month 18	CNI-regimen		54.2	Standard Deviation 17.9	mL/min
Calculated Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula at Month 18	CNI-free-regimen		66.9	Standard Deviation 23.0	mL/min
Occurrence of Treatment Failures From Month 6 to 9 and Month 9 to 18	CNI-regimen	Month 6 to Month 9 Treatment failure - all reasons	1		Occurences
Occurrence of Treatment Failures From Month 6 to 9 and Month 9 to 18	CNI-free-regimen	Month 6 to Month 9 Treatment failure - all reasons	4		Occurences
Occurrence of Treatment Failures From Month 6 to 9 and Month 9 to 18	CNI-regimen	Month 9 to Month 18 Treatment failure-all reasons	3		Occurences
Occurrence of Treatment Failures From Month 6 to 9 and Month 9 to 18	CNI-free-regimen	Month 9 to Month 18 Treatment failure-all reasons	15		Occurences
Occurrence of Major Cardiac Events (MACE) From Month 6 to 18	CNI-regimen	Myocardial infarction	1		Occurences
Occurrence of Major Cardiac Events (MACE) From Month 6 to 18	CNI-free-regimen	Myocardial infarction	0		Occurences
Occurrence of Major Cardiac Events (MACE) From Month 6 to 18	CNI-regimen	Death	0		Occurences
Occurrence of Major Cardiac Events (MACE) From Month 6 to 18	CNI-free-regimen	Death	1		Occurences

1 to 10 of 28Source ClinicalTrials.gov

See all 28 results by group

Participant flow8

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

Period	Milestone	Group	Participants
Overall Study	STARTED	CNI-regimen	84
Overall Study	STARTED	CNI-free-regimen	78
Overall Study	Full Analysis Set (FAS)	CNI-regimen	74
Overall Study	Full Analysis Set (FAS)	CNI-free-regimen	71
Overall Study	COMPLETED	CNI-regimen	76
Overall Study	COMPLETED	CNI-free-regimen	71
Overall Study	NOT COMPLETED	CNI-regimen	8
Overall Study	NOT COMPLETED	CNI-free-regimen	7

Source ClinicalTrials.gov

Adverse events278

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	CNI-regimen	6	84
other	ANAEMIA	Blood and lymphatic system disorders	CNI-free-regimen	7	78
other	LEUKOPENIA	Blood and lymphatic system disorders	CNI-regimen	10	84
other	LEUKOPENIA	Blood and lymphatic system disorders	CNI-free-regimen	10	78
other	SINUS TACHYCARDIA	Cardiac disorders	CNI-regimen	3	84
other	SINUS TACHYCARDIA	Cardiac disorders	CNI-free-regimen	5	78
other	TACHYCARDIA	Cardiac disorders	CNI-regimen	8	84
other	TACHYCARDIA	Cardiac disorders	CNI-free-regimen	7	78
other	HYPERTHYROIDISM	Endocrine disorders	CNI-regimen	6	84
other	HYPERTHYROIDISM	Endocrine disorders	CNI-free-regimen	4	78

1 to 10 of 278Source ClinicalTrials.gov

See all 278 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	CNI-regimen	0	84
Total, all-cause mortality	CNI-free-regimen	1	78
Total, other adverse events	CNI-regimen	74	84
Total, other adverse events	CNI-free-regimen	65	78
Total, serious adverse events	CNI-regimen	40	84
Total, serious adverse events	CNI-free-regimen	29	78

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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 comparisons2

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

Comparison	Source
CNI-regimen vs CNI-free-regimen: deaths from any cause	Trial comparisons
CNI-regimen vs CNI-free-regimen: serious adverse events	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/NCT00862979

GET https://conductscience.org/api/trials/v1/NCT00862979/results?page=2

API reference For AI assistants