Renal TransplantationPhase 3NCT00425308

Efficacy and Safety of Everolimus in Combination With Cyclosporine Microemulsion Versus Everolimus in Combination With Enteric-coated Mycophenolate Sodium (EC-MPS), in Adult Renal Transplant Patients in Maintenance.

A Phase 3 study testing Everolimus + Cyclosporine, Everolimus + Enteric-coated Mycophenolate Sodium (EC-MPS) and Steroids in people with Renal Transplantation, run by Novartis Pharmaceuticals at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Renal Transplantation
What is being tested?: Everolimus + Cyclosporine, Everolimus + Enteric-coated Mycophenolate Sodium (EC-MPS) and Steroids
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteFrance
Study dates: Oct 2006to May 2009
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Adult, Older adult

Who may be able to join

Patients who participated in and completed study CRAD001A2420

Who cannot join

Premature study or study treatment discontinuation in CRAD001A2420 study.
Acute rejection within the 3 months prior to inclusion
Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

1 site in 1 country.

France1 site

Novartis Investigative Site
Paris

Other trials in France

About this study

Official title: A Prospective Multicenter Open-label Randomized Study to Assess Efficacy and Safety of Everolimus in Combination With Cyclosporine Microemulsion Versus Everolimus Without Calcineurine Inhibitor in Combination With Enteric-coated Mycophenolate Sodium (EC-MPS), in Adult Renal Transplant Patients in Maintenance.

Efficacy and safety of 2 groups of treatment: everolimus in association with cyclosporine microemulsion and steroids versus everolimus in association with Enteric-coated Mycophenolate Sodium (EC-MPS) and steroids. The study population consists of patients having taken part in study CRAD001A2420 (NCT00154297) until the end (12 months) and having not prematurely discontinued the immunosuppressive regimen received in this study (everolimus + cyclosporine microemulsion + steroids).

Conditions: Renal Transplantation
Being tested: Everolimus + Cyclosporine, Everolimus + Enteric-coated Mycophenolate Sodium (EC-MPS), Steroids
Keywords: Everolimus, calcineurine inhibitor, renal transplantation in maintenance, chronic allograft nephropathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Everolimus + CyclosporineDrug
Also called Cyclosporine Microemulsion, Neoral
Everolimus + Enteric-coated Mycophenolate Sodium (EC-MPS)Drug
Also called Myfortic
SteroidsDrug

Study groups in NCT00425308
Study group	Role	What they receive
Everolimus + Enteric-coated Mycophenolate Sodium (EC-MPS)	Active comparator	Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids Receives: Drug: Everolimus + Enteric-coated Mycophenolate Sodium (EC-MPS); Drug: Steroids
Everolimus + Cyclosporine	Active comparator	Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids Receives: Drug: Everolimus + Cyclosporine; Drug: Steroids

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Glomerular Filtration Rate Estimated by Iohexol Plasma Clearance 12 Months After Randomization Between the 2 Groups of Patients.
Primary efficacy endpoint: between treatment analysis of change in iohexol plasmatic clearance (mL/min) from baseline to Month 12 (M12)
Measured: From Baseline to Month 12
Change in the Glomerular Filtration Rate Estimated by Iohexol Plasma Clearance 12 Months After Randomization Between the 2 Groups of Patients Who Completed Trial
Primary efficacy endpoint: between treatment analysis of change in iohexol plasmatic clearance (mL/min) from baseline to Month 12 (M12)
Measured: From Baseline to Month 12

Secondary outcomes (10)

Change in Renal Function Assessed by Serum Creatinine at Month 3, Month 6 and Month 12
Measured: From Baseline to Month 3, 6, and 12
Number of Participants With Biopsy-proven Acute Rejection (BPAR) at Month 6 and Month 12.
Measured: Month 6 and 12
Number of Participants With Treatment Failures Assessed by Biopsy-proven Acute Rejection (BPAR), Graft Loss/Re-transplantation, Death or Lost to Follow-up at Month 12.
Measured: Month 12
Change in Renal Function Assessed by Creatinine Clearance at Month 3, Month 6 and Month 12
Change in creatinine clearance, Nankivell formula (mL/min/1.73m²) from baseline to M12
Measured: From Baseline to Month 3, 6, and 12
Change in Renal Function Assessed by Proteinuria at Month 3, Month 6 and Month 12
Change in proteinuria (g/24h) from baseline to M12
Measured: From Baseline to Month 3, 6, and 12
Assessing Cardiovascular Risk Factors Based on Fasting Glucose.
Blood chemistry - fasting glycemia (mmol/L)
Measured: From Baseline to Month 1, 3, 6, 9, and 12
Assessing Cardiovascular Risk Factors Based on Fasting Total Cholesterol.
Blood chemistry - total cholesterol (mmol/L)
Measured: From Baseline to Month 1, 3, 6, 9, and 12
Assessing Cardiovascular Risk Factors Based on Fasting High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol.
Measured: From Baseline to Month 3, 6, and 12
Assessing Cardiovascular Risk Factors Based on Fasting Triglycerides.
Measured: From Baseline to Month 1, 3, 6, 9, and 12
Assessing Cardiovascular Risk Factors Based on Fasting C-reactive Protein (CRP).
Blood chemistry - C-reactive Protein (CRP) (mg/L)
Measured: From Baseline to Month 3, 6, and 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2006May 2009

First posted22 Jan 2007 (estimated)
Study startOct 2006
Primary completionMay 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Renal TransplantationStudies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00425308
Sponsor's protocol ID: CRAD001AFR06
Status last verified: Feb 2017
First submitted: 19 Jan 2007
Last updated: 30 Mar 2017
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
RecruitingPhase 2
A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
Antibody-Mediated Rejection (AMR)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruitingEarly Phase 1
Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
Kidney Transplant Recipient
Recruiting
Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
Pediatric Kidney Disease, Transplant;Failure,Kidney

All Renal Transplantation trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Multicenter Open-label Randomized Study to Assess Efficacy and Safety of Everolimus in Combination With Cyclosporine Microemulsion Versus Everolimus Without Calcineurine Inhibitor in Combination With Enteric-coated Mycophenolate Sodium (EC-MPS), in Adult Renal Transplant Patients in Maintenance.
ClinicalTrials.gov ID: NCT00425308
Acronym / sponsor ID: CRAD001AFR06
Conditions: Renal Transplantation
Keywords: Everolimus, calcineurine inhibitor, renal transplantation in maintenance, chronic allograft nephropathy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Oct 2006
Primary completion: May 2009 (actual)
First posted: 22 Jan 2007 (estimated)
Results: Posted 19 Apr 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Everolimus + Enteric-coated Mycophenolate Sodium (EC-MPS)	Active comparator	Drug: Everolimus + Enteric-coated Mycophenolate Sodium (EC-MPS), Drug: SteroidsEverolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
Everolimus + Cyclosporine	Active comparator	Drug: Everolimus + Cyclosporine, Drug: SteroidsEverolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids

Who may qualify

Ages: 18 years and older
Sex: All
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Patients who participated in and completed study CRAD001A2420

Key exclusion criteria (3 listed)

Premature study or study treatment discontinuation in CRAD001A2420 study.
Acute rejection within the 3 months prior to inclusion
Other protocol-defined inclusion/exclusion criteria may apply

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Everolimus + CyclosporineAlso: Cyclosporine Microemulsion, Neoral	Drug	Everolimus + Cyclosporine
Everolimus + Enteric-coated Mycophenolate Sodium (EC-MPS)Also: Myfortic	Drug	Everolimus + Enteric-coated Mycophenolate Sodium (EC-MPS)
Steroids	Drug	Everolimus + Cyclosporine, Everolimus + Enteric-coated Mycophenolate Sodium (EC-MPS)

Primary outcome

Change in Glomerular Filtration Rate Estimated by Iohexol Plasma Clearance 12 Months After Randomization Between the 2 Groups of Patients.
Time frame: From Baseline to Month 12
Primary efficacy endpoint: between treatment analysis of change in iohexol plasmatic clearance (mL/min) from baseline to Month 12 (M12)
Change in the Glomerular Filtration Rate Estimated by Iohexol Plasma Clearance 12 Months After Randomization Between the 2 Groups of Patients Who Completed Trial
Time frame: From Baseline to Month 12
Primary efficacy endpoint: between treatment analysis of change in iohexol plasmatic clearance (mL/min) from baseline to Month 12 (M12)

10 secondary outcomes

Change in Renal Function Assessed by Serum Creatinine at Month 3, Month 6 and Month 12
Time frame: From Baseline to Month 3, 6, and 12
Number of Participants With Biopsy-proven Acute Rejection (BPAR) at Month 6 and Month 12.
Time frame: Month 6 and 12
Number of Participants With Treatment Failures Assessed by Biopsy-proven Acute Rejection (BPAR), Graft Loss/Re-transplantation, Death or Lost to Follow-up at Month 12.
Time frame: Month 12
Change in Renal Function Assessed by Creatinine Clearance at Month 3, Month 6 and Month 12
Time frame: From Baseline to Month 3, 6, and 12
Change in Renal Function Assessed by Proteinuria at Month 3, Month 6 and Month 12
Time frame: From Baseline to Month 3, 6, and 12
Assessing Cardiovascular Risk Factors Based on Fasting Glucose.
Time frame: From Baseline to Month 1, 3, 6, 9, and 12
Assessing Cardiovascular Risk Factors Based on Fasting Total Cholesterol.
Time frame: From Baseline to Month 1, 3, 6, 9, and 12
Assessing Cardiovascular Risk Factors Based on Fasting High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol.
Time frame: From Baseline to Month 3, 6, and 12
Assessing Cardiovascular Risk Factors Based on Fasting Triglycerides.
Time frame: From Baseline to Month 1, 3, 6, 9, and 12
Assessing Cardiovascular Risk Factors Based on Fasting C-reactive Protein (CRP).
Time frame: From Baseline to Month 3, 6, and 12

Results and safety

Results posted to the registry on 19 Apr 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cyclosporine	15	11
Enteric-coated Mycophenolate Sodium (EC-MPS)	15	14

Primary outcome: Change in Glomerular Filtration Rate Estimated by Iohexol Plasma Clearance 12 Months After Randomization Between the 2 Groups of Patients.

Time frame: From Baseline to Month 12. Least squares mean (Standard Error). Unit: (mL/min)

Measure	Cyclosporine n = 13	Enteric-coated Mycophenolate Sodium (EC-MPS) n = 14
Value	-4.07 (5.03)	10.30 (4.84)

Population analysed: Intent to Treat (ITT) Population: all patients with a baseline value

Primary outcome: Change in the Glomerular Filtration Rate Estimated by Iohexol Plasma Clearance 12 Months After Randomization Between the 2 Groups of Patients Who Completed Trial

Time frame: From Baseline to Month 12. Least squares mean (Standard Error). Unit: (mL/min)

Measure	Cyclosporine n = 8	Enteric-coated Mycophenolate Sodium (EC-MPS) n = 13
Value	1.46 (6.60)	12.00 (5.06)

Population analysed: Intent to Treat (ITT) Population: completed patients

10 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cyclosporine	8 of 15 (53.3%)	11 of 15 (73.3%)	Not reported
Enteric-Coated Mycophenolate Sodium (EC-MPS)	10 of 15 (66.7%)	14 of 15 (93.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Renal Transplantation

Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
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RecruitingPhase 2
A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
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Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruitingEarly Phase 1
Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
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Recruiting
Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Novartis study director

Novartis

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Apr 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Glomerular Filtration Rate Estimated by Iohexol Plasma Clearance 12 Months After Randomization Between the 2 Groups of Patients. (time frame: From Baseline to Month 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00425308.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2017.