Kidney DiseasesPhase 3OLYMPENCT00284934

Enteric-coated Mycophenolate Sodium (EC-MPS) With Reduced-dose Tacrolimus Versus EC-MPS With Standard-dose Tacrolimus in Stable Kidney Transplant Recipients

A Phase 3 study testing Enteric-coated mycophenolate sodium (EC-MPS), Tacrolimus and Corticosteroids in people with Kidney Diseases, run by Novartis at 1 site in Switzerland.

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

This study introduces a new optimization immunosuppressive regimen associating tacrolimus at a reduced dose and enteric-coated mycophenolate sodium at an increased dose in order to slow down renal function worsening and to prevent the progression of chronic allograft nephropathy, while maintaining the same efficacy… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Kidney Diseases
What is being tested?: Enteric-coated mycophenolate sodium (EC-MPS), Tacrolimus and Corticosteroids
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 94 participants
Where: 1 siteSwitzerland
Study dates: Dec 2005to Jun 2008
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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Primary or secondary kidney transplant
Treatment with mycophenolic acid (MMF 1 g/d or EC-MPS 720 mg/d) and tacrolimus (trough concentration [C0] ≥ 5.5 ng/mL)
Creatinine clearance ≥ 30 mL/min and < 60 mL/min and stable renal function

Who cannot join

Multi-organ recipients or previous transplant with any other organ different from kidney
Biopsy proven acute rejection or treated acute rejection within the last 3 months.
Prescription of mycophenolate mofetil 1 g/d or mycophenolate sodium 720 mg/d due to adverse event occurrence when higher doses were administered
Other protocol-defined inclusion/exclusion criteria may apply.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

Novartis
Basel

Other trials in Switzerland

About this study

Official title: A Multicenter, National, Open-label, Prospective, Randomized Study to Evaluate Efficacy and Tolerability of Enteric-coated Mycophenolate Sodium 1440 mg/Day With Tacrolimus Reduced Dose Versus Enteric-coated Mycophenolate Sodium 720 mg/Day With Tacrolimus Standard Dose, in Maintenance, Stable, Adult, Kidney Transplant Recipients

Conditions: Kidney Diseases
Being tested: Enteric-coated mycophenolate sodium (EC-MPS), Tacrolimus, Corticosteroids
Keywords: Dose optimization, immune suppressive regimen, enteric-coated mycophenolate sodium, EC-MPS, renal transplantation, kidney, transplant, maintenance patients, Renal transplantation in maintenance
Medical subject headings: Kidney Diseases

What participants receive

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

Enteric-coated mycophenolate sodium (EC-MPS)Drug
Also called Myfortic
TacrolimusDrug
Also called Prograf
CorticosteroidsDrug
Also called Prednisone
At a dose of at least 5 mg/day.

Study groups in NCT00284934
Study group	Role	What they receive
Standard dose EC-MPS	Active comparator	Patients received 720 mg/day (360 mg twice a day (bid) orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus dose (twice a day orally) adjusted to maintain the trough blood level (C0) contained between 5.5 and 10 ng/mL. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center's standard practice, but at a dose of at least 5 mg/day. Receives: Drug: Enteric-coated mycophenolate sodium (EC-MPS); Drug: Tacrolimus; Drug: Corticosteroids
High EC-MPS	Experimental	Patients received 1440 mg/day (720 mg twice a day (bid) orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus dose (twice a day orally) tapered to reach a trough blood level target contained between 2 and 4.5 ng/mL within 15 days after randomization at the most. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center's standard practice, but at a dose of at least 5 mg/day. Receives: Drug: Enteric-coated mycophenolate sodium (EC-MPS); Drug: Tacrolimus; Drug: Corticosteroids

What is being measured

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

Renal Function Assessed by Change in Estimated Glomerular Filtration Rate(eGFR)
Change in estimated glomerular filtration rate from baseline to Month 6 calculated by using abbreviated Modification of Diet in Renal Disease (MDRD) formula. Modification of Diet in Renal Disease (MDRD) formula is: GFR [mL/min/1.73m^2] = 186.3*(C^-1.154)*(A^-0.203)*G*R where -C is the serum concentration of creatinine [mg/dL], -A is patient age at sample collection date [years], -G=0.742 when gender is female, otherwise G=1, -R=1.21 when race is black, otherwise R=1.
Measured: Baseline and Month 6

Secondary outcomes (3)

Renal Function at 3 Months Assessed by Change in Estimated Glomerular Filtration Rate (eGFR)
Change in estimated glomerular filtration rate from baseline to Month 3 calculated by using abbreviated MDRD formula. Modification of Diet in Renal Disease (MDRD) formula is: GFR [mL/min/1.73m^2] = 186.3*(C^-1.154)*(A^-0.203)*G*R where -C is the serum concentration of creatinine [mg/dL], -A is patient age at sample collection date [years], -G=0.742 when gender is female, otherwise G=1, -R=1.21 when race is black, otherwise R=1.
Measured: Baseline and 3 months
Number of Participants With Treatment Failure Parameters (Biopsy-Proven Acute Rejection (BPAR), Graft Loss, Death, or Loss to Follow-up) at 6 Months
A biopsy-proven acute rejection (BPAR) is defined as a biopsy graded IA, IB, IIA, IIB, or III based on the Banff 1997 classification.The allograft was presumed lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis. If the patient went through a graft nephrectomy, then the day of nephrectomy was the day of graft loss.
Measured: 6 months
Number of Participants With Graft and Patient Survivals at 6 Months
Graft survival was defined as the number of patients with no graft loss. The allograft was presumed lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis. If the patient went through a graft nephrectomy, then the day of nephrectomy was the day of graft loss. Patient survival was defined as the number of patients alive with or without a functioning graft.
Measured: 6 months

Timeline

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

Dec 2005Jun 2008

First posted1 Feb 2006 (estimated)
Study startDec 2005
Primary completionJun 2008
Study completionJun 2008

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Kidney DiseasesStudies of the same condition, open and under way.
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: 94 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00284934
Sponsor's protocol ID: CERL080AFR04
Acronym: OLYMPE
Status last verified: Mar 2011
First submitted: 30 Jan 2006
Last updated: 2 May 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Kamar N, Rostaing L, Cassuto E, Villemain F, Moal MC, Ladriere M, Barrou B, Ducloux D, Chaouche K, Quere S, Di Giambattista F, Be F. A multicenter, randomized trial of increased mycophenolic acid dose using enteric-coated mycophenolate sodium with reduced tacrolimus exposure in maintenance kidney transplant recipients. Clin Nephrol. 2012 Feb;77(2):126-36. doi: 10.5414/CN107227.
PubMed 22257543

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

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Study at a glance

From the registry record, last updated by the sponsor on 2 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, National, Open-label, Prospective, Randomized Study to Evaluate Efficacy and Tolerability of Enteric-coated Mycophenolate Sodium 1440 mg/Day With Tacrolimus Reduced Dose Versus Enteric-coated Mycophenolate Sodium 720 mg/Day With Tacrolimus Standard Dose, in Maintenance, Stable, Adult, Kidney Transplant Recipients
ClinicalTrials.gov ID: NCT00284934
Acronym / sponsor ID: OLYMPE / CERL080AFR04
Conditions: Kidney Diseases
Keywords: Dose optimization, immune suppressive regimen, enteric-coated mycophenolate sodium, EC-MPS, renal transplantation, kidney, transplant, maintenance patients
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 94 participants (actual)
Lead sponsor: NovartisIndustry (pharma, biotech, devices)
Study start: Dec 2005
Primary completion: Jun 2008 (actual)
Study completion: Jun 2008 (actual)
First posted: 1 Feb 2006 (estimated)
Results: Posted 2 May 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
Standard dose EC-MPS	Active comparator	Drug: Enteric-coated mycophenolate sodium (EC-MPS), Drug: Tacrolimus, Drug: CorticosteroidsPatients received 720 mg/day (360 mg twice a day (bid) orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus dose (twice a day orally) adjusted to maintain the trough blood level (C0) contained between 5.5 and 10 ng/mL. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center's standard practice, but at a dose of at least 5 mg/day.
High EC-MPS	Experimental	Drug: Enteric-coated mycophenolate sodium (EC-MPS), Drug: Tacrolimus, Drug: CorticosteroidsPatients received 1440 mg/day (720 mg twice a day (bid) orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus dose (twice a day orally) tapered to reach a trough blood level target contained between 2 and 4.5 ng/mL within 15 days after randomization at the most. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center's standard practice, but at a dose of at least 5 mg/day.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Primary or secondary kidney transplant
Treatment with mycophenolic acid (MMF 1 g/d or EC-MPS 720 mg/d) and tacrolimus (trough concentration [C0] ≥ 5.5 ng/mL)
Creatinine clearance ≥ 30 mL/min and < 60 mL/min and stable renal function

Key exclusion criteria (4 listed)

Multi-organ recipients or previous transplant with any other organ different from kidney
Biopsy proven acute rejection or treated acute rejection within the last 3 months.
Prescription of mycophenolate mofetil 1 g/d or mycophenolate sodium 720 mg/d due to adverse event occurrence when higher doses were administered
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
Enteric-coated mycophenolate sodium (EC-MPS)Also: Myfortic	Drug	High EC-MPS, Standard dose EC-MPS
TacrolimusAlso: Prograf	Drug	High EC-MPS, Standard dose EC-MPS
CorticosteroidsAlso: PrednisoneAt a dose of at least 5 mg/day.	Drug	High EC-MPS, Standard dose EC-MPS

Primary outcome

Renal Function Assessed by Change in Estimated Glomerular Filtration Rate(eGFR)
Time frame: Baseline and Month 6
Change in estimated glomerular filtration rate from baseline to Month 6 calculated by using abbreviated Modification of Diet in Renal Disease (MDRD) formula. Modification of Diet in Renal Disease (MDRD) formula is: GFR [mL/min/1.73m^2] = 186.3*(C^-1.154)*(A^-0.203)*G*R where -C is the serum concentration of creatinine [mg/dL], -A is patient age at sample collection date [years], -G=0.742 when gender is female, otherwise G=1, -R=1.21 when race is black, otherwise R=1.

3 secondary outcomes

Renal Function at 3 Months Assessed by Change in Estimated Glomerular Filtration Rate (eGFR)
Time frame: Baseline and 3 months
Number of Participants With Treatment Failure Parameters (Biopsy-Proven Acute Rejection (BPAR), Graft Loss, Death, or Loss to Follow-up) at 6 Months
Time frame: 6 months
Number of Participants With Graft and Patient Survivals at 6 Months
Time frame: 6 months

Results and safety

Results posted to the registry on 2 May 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
Standard Dose EC-MPS	48	44
High EC-MPS	46	43

Primary outcome: Renal Function Assessed by Change in Estimated Glomerular Filtration Rate(eGFR)

Time frame: Baseline and Month 6. Mean (Standard Deviation). Unit: mL/min/1.73m^2

Measure	Standard Dose EC-MPS n = 47	High EC-MPS n = 45
Baseline (n= 47, 45)	45.3 (9.5)	56.4 (11.2)
Month 6 (n= 45, 43)	44.7 (11.5)	49.1 (11.11)
Change from Baseline - Month 6 (n= 45, 43)	-0.4 (6.9)	2.4 (6.1)

Population analysed: Intent-to-treat (ITT) population was defined as all patients who were randomized and treated with study medication and had at least one post-treatment efficacy assessment.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard Dose EC-MPS	8 of 47 (17%)	4 of 47 (8.5%)	Not reported
High EC-MPS	7 of 45 (15.6%)	10 of 45 (22.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22257543Kamar N, Rostaing L, Cassuto E, Villemain F, Moal MC, Ladriere M, Barrou B, Ducloux D, Chaouche K, Quere S, Di Giambattista F, Be F. A multicenter, randomized trial of increased mycophenolic acid dose using enteric-coated mycophenolate sodium with reduced tacrolimus exposure in maintenance kidney transplant recipients. Clin Nephrol. 2012 Feb;77(2):126-36. doi: 10.5414/CN107227.

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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?

A Phase 3 study testing Enteric-coated mycophenolate sodium (EC-MPS), Tacrolimus and Corticosteroids in people with Kidney Diseases, run by Novartis at 1 site in Switzerland.

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 3 inclusion and 4 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 2 May 2011. 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 Switzerland. 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 2 May 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?

Renal Function Assessed by Change in Estimated Glomerular Filtration Rate(eGFR) (time frame: Baseline and Month 6). 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 NCT00284934, which also lists 1 linked publication.

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 2 May 2011.