Kidney TransplantationPhase 4NCT01033864

A Pharmacokinetic Study of CellCept (Mycophenolate Mofetil) Versus Mycophenolate Sodium in Kidney Transplant Patients

A Phase 4 study testing MMF, EC-MPS and Prednisone in people with Kidney Transplantation, run by Hoffmann-La Roche at 1 site in Germany.

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: Kidney Transplantation
What is being tested?: MMF, EC-MPS and Prednisone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 23 participants
Where: 1 siteGermany
Study dates: Nov 2009to Jun 2010
Phase: Phase 4
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
No healthy volunteers
Adult, Older adult

Who may be able to join

adult patients, >/=18 years of age
kidney transplantation >/=6 months ago
on mycophenolic acid-based, calcineurininhibitor-free therapy for >/=3 months, >/=1 month on stable dose
co-therapy with 5mg prednisone for >/=1 month

Who cannot join

active gastrointestinal ulcus
severe diarrhea od gastrointestinal disease
severe impairment of renal function
current malignancy
Lesch-Nyhan- or Kelley-Seegmiller-Syndrome

Trial locations and contacts

1 site in 1 country.

Germany1 site

Study site
Frankfurt am Main, 60528

Other trials in Germany

About this study

Official title: Comparison of Pharmocokinetics of Mycophenolate Mofetil and Enteric Coated Mycophenolate Sodium in Calcineurininhibitor-free Treated Patients After Renal Transplantation

This open-label, 2-arm study will compare the pharmacokinetics of CellCept and mycophenolate sodium in kidney transplanted patients on a calcineurininhibitor-free mycophenolic acid-based therapy. On the study day patients will take their prescribed medication (either CellCept or mycophenolate sodium). Blood samples will be drawn directly before and at intervals up to 12 hours after intake of the study medication. Anticipated time on study treatment is 12 hours and target sample size is 24.

Conditions: Kidney Transplantation
Being tested: MMF, EC-MPS, Prednisone

What participants receive

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

MMFDrug
Also called CellCept, mycophenolate mofetil
1 g per day b.i.d. p.o. for at least 1 month
EC-MPSDrug
Also called mycophenolate sodium
720 mg b.i.d. p.o. for at least 1 month
PrednisoneDrug
5 mg per day p.o.

Study groups in NCT01033864
Study group	Role	What they receive
MMF, Prednisone	Experimental	Participants received mycophenolate mofetil (MMF) orally (PO) at a dose of 1 gram per day (g/day) twice daily (BID), and prednisone, PO, up to 5 milligrams per day (mg/day) for at least 1 month. Receives: Drug: MMF; Drug: Prednisone
EC-MPS	Active comparator	Participants received mycophenolate sodium (EC-MPS), PO, at a dose of 720 mg/day BID, and prednisone PO up to 5 mg/day for at least 1 month. Receives: Drug: EC-MPS; Drug: Prednisone

What is being measured

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

Pre-dose Trough Concentration (C0)
The mean mycophenolic acid (MPA) concentration in plasma was determined (in milligrams per liter [mg/L]) from blood samples collected predose (immediately before receiving study treatment).
Measured: Day 1 predose
Dose-Normalized C0
Dose normalized C0 was determined (in mg/L) from blood samples collected predose. Both MMF and EC-MPS doses were normalized to a standard dose of 1 g MMF or 720 mg EC-MPS, respectively. The dose normalization was calculated as follows:
For the MMF group: Dose normalized C0 equals (=) C0 divided by (/) (actual dose taken/1000) For the EC-MPS group: Dose normalized C0 = C0 / (actual dose taken/720)
Measured: Day 1 predose
Minimum Plasma Concentration (Cmin)
The mean minimum MPA concentration in plasma was determined (in mg/L) from blood samples collected predose and postdose on Day 1.
Measured: Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours
Dose-Normalized Cmin
Dose-normalized Cmin was determined (in mg/L) from blood samples collected predose and postdose. Both MMF and EC-MPS doses were normalized to a standard dose of 1 g MMF or 720 mg EC-MPS, respectively. The dose normalization was calculated as follows:
For the MMF group: Dose normalized Cmin = Cmin/ (actual dose taken/1000) For the EC-MPS group: Dose normalized Cmin = Cmin / (actual dose taken/720)
Measured: Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours
Maximum Plasma Concentration (Cmax)
The mean maximum MPA concentration in plasma was determined (in mg/L) in blood samples collected predose and postdose on Day 1.
Measured: Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours
Dose-Normalized Cmax (mg/L)
Dose-normalized Cmax in plasma was determined (in mg/L) from blood samples collected predose and postdose on Day 1. Both MMF and EC-MPS doses were normalized to a standard dose of 1 g MMF or 720 mg EC-MPS, respectively. The dose normalization was calculated as follows:
For the MMF group: Dose normalized Cmax = Cmax / (actual dose taken/1000) For the EC-MPS group: Dose normalized Cmax = Cmax / (actual dose taken/720)
Measured: Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours
MPA Area Under the Curve From 0 to 12 Hours (AUC0-12)
The mean MPA AUC0-12 in plasma was determined (in mg multiplied by hours, per Liter [mg*h/L]) from blood samples collected predose and postdose on Day 1.
Measured: Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours
Dose-Normalized MPA AUC0-12
Dose-normalized MPA AUC0-12 in plasma was determined (mg*h/L) from blood samples collected predose and postdose on Day 1. Both MMF and EC-MPS doses were normalized to a standard dose of 1 g MMF or 720 mg EC-MPS, respectively. The dose normalization was calculated as follows:
For the MMF group: Dose normalized MPA AUC = MPA AUC / (actual dose taken/1000) For the EC-MPS group: Dose normalized MPA AUC = MPA AUC / (actual dose taken/720)
Measured: Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours
Percentage of Participants By Time to Maximum Plasma Concentration (Tmax)
Measured: Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours

Secondary outcomes (1)

Regression Coefficients For Participants Receiving MMF
The estimated regression coefficients for participants who received MMF presented in milligrams per liter (mg/L).
Measured: Day 1 at 30 minutes and 1 and 2 hours postdose

Timeline

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

Nov 2009Jun 2010

First posted17 Dec 2009 (estimated)
Study startNov 2009
Primary completionJun 2010
Study completionJun 2010

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 Kidney TransplantationStudies of the same condition, open and under way.
More trials run by Hoffmann-La RocheThe 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 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01033864
Sponsor's protocol ID: ML22641
Other IDs: 2009-012355-15, 2009
Status last verified: Aug 2015
First submitted: 16 Dec 2009
Last updated: 27 Aug 2015
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

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A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
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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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All Kidney Transplantation trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Pharmocokinetics of Mycophenolate Mofetil and Enteric Coated Mycophenolate Sodium in Calcineurininhibitor-free Treated Patients After Renal Transplantation
ClinicalTrials.gov ID: NCT01033864
Acronym / sponsor ID: ML22641
Conditions: Kidney Transplantation
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 23 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: Nov 2009
Primary completion: Jun 2010 (actual)
Study completion: Jun 2010 (actual)
First posted: 17 Dec 2009 (estimated)
Results: Posted 10 Oct 2014

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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
MMF, Prednisone	Experimental	Drug: MMF, Drug: PrednisoneParticipants received mycophenolate mofetil (MMF) orally (PO) at a dose of 1 gram per day (g/day) twice daily (BID), and prednisone, PO, up to 5 milligrams per day (mg/day) for at least 1 month.
EC-MPS	Active comparator	Drug: EC-MPS, Drug: PrednisoneParticipants received mycophenolate sodium (EC-MPS), PO, at a dose of 720 mg/day BID, and prednisone PO up to 5 mg/day for at least 1 month.

Who may qualify

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

Key inclusion criteria (4 listed)

adult patients, >/=18 years of age
kidney transplantation >/=6 months ago
on mycophenolic acid-based, calcineurininhibitor-free therapy for >/=3 months, >/=1 month on stable dose
co-therapy with 5mg prednisone for >/=1 month

Key exclusion criteria (5 listed)

active gastrointestinal ulcus
severe diarrhea od gastrointestinal disease
severe impairment of renal function
current malignancy
Lesch-Nyhan- or Kelley-Seegmiller-Syndrome

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
MMFAlso: CellCept, mycophenolate mofetil1 g per day b.i.d. p.o. for at least 1 month	Drug	MMF, Prednisone
EC-MPSAlso: mycophenolate sodium720 mg b.i.d. p.o. for at least 1 month	Drug	EC-MPS
Prednisone5 mg per day p.o.	Drug	EC-MPS, MMF, Prednisone

Primary outcome

Pre-dose Trough Concentration (C0)
Time frame: Day 1 predose
The mean mycophenolic acid (MPA) concentration in plasma was determined (in milligrams per liter [mg/L]) from blood samples collected predose (immediately before receiving study treatment).
Dose-Normalized C0
Time frame: Day 1 predose
Dose normalized C0 was determined (in mg/L) from blood samples collected predose. Both MMF and EC-MPS doses were normalized to a standard dose of 1 g MMF or 720 mg EC-MPS, respectively. The dose normalization was calculated as follows: For the MMF group: Dose normalized C0 equals (=) C0 divided by (/) (actual dose taken/1000) For the EC-MPS group: Dose normalized C0 = C0 / (actual dose taken/720)
Minimum Plasma Concentration (Cmin)
Time frame: Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours
The mean minimum MPA concentration in plasma was determined (in mg/L) from blood samples collected predose and postdose on Day 1.
Dose-Normalized Cmin
Time frame: Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours
Dose-normalized Cmin was determined (in mg/L) from blood samples collected predose and postdose. Both MMF and EC-MPS doses were normalized to a standard dose of 1 g MMF or 720 mg EC-MPS, respectively. The dose normalization was calculated as follows: For the MMF group: Dose normalized Cmin = Cmin/ (actual dose taken/1000) For the EC-MPS group: Dose normalized Cmin = Cmin / (actual dose taken/720)
Maximum Plasma Concentration (Cmax)
Time frame: Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours
The mean maximum MPA concentration in plasma was determined (in mg/L) in blood samples collected predose and postdose on Day 1.
Dose-Normalized Cmax (mg/L)
Time frame: Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours
Dose-normalized Cmax in plasma was determined (in mg/L) from blood samples collected predose and postdose on Day 1. Both MMF and EC-MPS doses were normalized to a standard dose of 1 g MMF or 720 mg EC-MPS, respectively. The dose normalization was calculated as follows: For the MMF group: Dose normalized Cmax = Cmax / (actual dose taken/1000) For the EC-MPS group: Dose normalized Cmax = Cmax / (actual dose taken/720)
MPA Area Under the Curve From 0 to 12 Hours (AUC0-12)
Time frame: Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours
The mean MPA AUC0-12 in plasma was determined (in mg multiplied by hours, per Liter [mg*h/L]) from blood samples collected predose and postdose on Day 1.
Dose-Normalized MPA AUC0-12
Time frame: Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours
Dose-normalized MPA AUC0-12 in plasma was determined (mg*h/L) from blood samples collected predose and postdose on Day 1. Both MMF and EC-MPS doses were normalized to a standard dose of 1 g MMF or 720 mg EC-MPS, respectively. The dose normalization was calculated as follows: For the MMF group: Dose normalized MPA AUC = MPA AUC / (actual dose taken/1000) For the EC-MPS group: Dose normalized MPA AUC = MPA AUC / (actual dose taken/720)
Percentage of Participants By Time to Maximum Plasma Concentration (Tmax)
Time frame: Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours

1 secondary outcome

Regression Coefficients For Participants Receiving MMF
Time frame: Day 1 at 30 minutes and 1 and 2 hours postdose

Results and safety

Results posted to the registry on 10 Oct 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mycophenolate Mofetil (MMF)/Prednisone	12	12
Enteric-coated Mycophenolate Sodium (EC-MPS)/Prednisone	11	11

Primary outcome: Pre-dose Trough Concentration (C0)

Time frame: Day 1 predose. Mean (Standard Deviation). Unit: mg/L

Measure	MMF/Prednisone n = 12	EC-MPS/Prednisone n = 11
Value	2.387 (1.1327)	2.944 (2.2103)

MMF/Prednisone vs EC-MPS/Prednisone: p = 0.8055, Wilcoxon (Mann-Whitney)

Population analysed: Pharmacokinetic (PK) population: all participants who took study drug and for whom all defined blood samples at the planned sampling time points were available.

Primary outcome: Dose-Normalized C0

Time frame: Day 1 predose. Mean (Standard Deviation). Unit: mg/L

Measure	MMF/Prednisone n = 12	EC-MPS/Prednisone n = 11
Value	2.962 (1.4439)	4.658 (3.1121)

MMF/Prednisone vs EC-MPS/Prednisone: p = 0.2548, Wilcoxon (Mann-Whitney)

Population analysed: PK population

Primary outcome: Minimum Plasma Concentration (Cmin)

Time frame: Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours. Mean (Standard Deviation). Unit: mg/L

Measure	MMF/Prednisone n = 12	EC-MPS/Prednisone n = 11
Value	1.385 (0.6061)	1.620 (0.6632)

MMF/Prednisone vs EC-MPS/Prednisone: p = 0.4417, Wilcoxon (Mann-Whitney)

Population analysed: PK population

Primary outcome: Dose-Normalized Cmin

Time frame: Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours. Mean (Standard Deviation). Unit: mg/L

Measure	MMF/Prednisone n = 12	EC-MPS/Prednisone n = 11
Value	1.702 (0.8018)	2.613 (1.0291)

MMF/Prednisone vs EC-MPS/Prednisone: p = 0.0455, Wilcoxon (Mann-Whitney)

Population analysed: PK population

1 secondary outcome is reported in the full results.

Adverse events

Time frame: The observational period, approximately 13 hours.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MMF/Prednisone	0 of 12 (0%)	0 of 12 (0%)	Not reported
EC-MPS/Prednisone	0 of 11 (0%)	0 of 11 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Kidney Transplantation

Enrolling by invitation
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A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
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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.

Clinical Trials study director

Hoffmann-La Roche

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing MMF, EC-MPS and Prednisone in people with Kidney Transplantation, run by Hoffmann-La Roche at 1 site in Germany.

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 4 inclusion and 5 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 27 Aug 2015. 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 Germany. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 10 Oct 2014). 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?

Pre-dose Trough Concentration (C0) (time frame: Day 1 predose). The study lists 9 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 NCT01033864.

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 27 Aug 2015.