Kidney TransplantationPhase 4NCT00758602

A Study of CellCept (Mycophenolate Mofetil) Combined With Tacrolimus and Corticosteroids in Kidney Transplant Patients.

A Phase 4 study testing mycophenolate mofetil, tacrolimus, standard dose and tacrolimus, low dose in people with Kidney Transplantation, run by Hoffmann-La Roche at 6 sites in China.

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 Up to 75 years
Conditions the study is for: Kidney Transplantation
What is being tested?: mycophenolate mofetil, tacrolimus, standard dose and tacrolimus, low dose
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 210 participants
Where: 6 sitesChina
Study dates: Sep 2008to Feb 2011
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 Up to 75 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

adult patients, <=75 years of age;
single organ recipients of renal allograft;
negative pregnancy test for women of childbearing potential; reliable contraception must be used before starting drug therapy, until 6 weeks after the last dose of study medication.

Who cannot join

severe gastrointestinal disease which may influence the absorption of oral drug therapy;
severe infection, HIV or active hepatitis;
active gastric ulcers;
malignancy other than cured skin cancer;
severe anemia, leucopenia or thrombocytopenia.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

China6 sites

Study site
Beijing, 100020
Study site
Fuzhou, 350025
Study site
Guangzhou, 510080
Study site
Nanjing, 210008
Study site
Shanghai, 200025
Study site
Zhejiang, 310003

Other trials in China

About this study

Official title: A Randomized, Open Label Study Comparing the Effect of CellCept Combined With Low Dose Versus Standard Dose Tacrolimus, and Corticosteroids, on Kidney Function in Renal Transplantation Patients

This 2 arm study will compare the efficacy and safety of CellCept, combined with low or standard dose tacrolimus plus corticosteroids, in patients with kidney transplants. Patients will be randomized into one of 2 groups to receive either 1)CellCept 2.0g/day po bid + tacrolimus 10-12ng/mL followed by a maintenance dose of 8-10ng/mL + corticosteroids or 2)CellCept 2.0g/day po bid + tacrolimus 8-10ng/mL in the first 2 months,3-7ng/mL in month 3 followed by a maintenance dose of 3-5ng/mL + corticosteroids. The anticipated time on study treatment is 1 year, and the target sample size is 100-500 individuals.

Conditions: Kidney Transplantation
Being tested: mycophenolate mofetil, tacrolimus, standard dose, tacrolimus, low dose, corticosteroids

What participants receive

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

mycophenolate mofetilDrug
Also called CellCept
0.75-1 g PO BID from Day 0 through Month 12
tacrolimus, standard doseDrug
Initial dose of 0.1-0.15 mg/kg PO BID to reach a target trough dose of 8-10 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 7-10 ng/mL in Month 3 and continued through Month 12.
tacrolimus, low doseDrug
Initial dose of 0.1-0.15 mg/kg PO BID to reach a target trough dose of 8 to 10 ng/mL from Day 0 through Month 3; 0.05-0.08 mg/kg PO BID to reach a target trough dose of 2-5 ng/mL in Month 3 and continued through Month 12.
corticosteroidsDrug
According to center's practice

Study groups in NCT00758602
Study group	Role	What they receive
MMF, Standard Dose Tacrolimus	Active comparator	Participants received mycophenolate mofetil (MMF) 0.75 to (-) 1 gram (g), orally (PO), twice daily (BID) from Day 0 through Month 12. Participants also received tacrolimus 0.1-0.15 milligrams per kilogram (mg/kg), PO, BID to reach a target trough dose of 8-10 nanograms per milliliter (ng/mL) from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 7-10 ng/mL in Month 3 and continued through Month 12. Participants also received corticosteroids per center practice. Receives: Drug: mycophenolate mofetil; Drug: tacrolimus, standard dose; Drug: corticosteroids
MMF, Low Dose Tacrolimus	Experimental	Participants received MMF 0.75-1 g, PO, BID from Day 0 through Month 12. Participants also received tacrolimus 0.1-0.15 mg/kg, PO, BID to reach a target trough dose of 8-10 ng/mL from Day 0 through Month 3; the dose was adjusted to 0.05-0.08 mg/kg, PO, BID to reach a target trough dose of 2-5 ng/mL in Month 3 and continued through Month 12. Participants also received corticosteroids per center practice. Receives: Drug: mycophenolate mofetil; Drug: tacrolimus, low dose; Drug: corticosteroids

What is being measured

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

Chronic Allograft Damage Index (CADI) Score at Month 12 After Transplantation
CADI scoring was defined for 6 histological categories: interstitial inflammatory cell infiltration (0 equals (=) no or mild inflammation, 1=approximately (~)25 percent (%) cell infiltration, 2=26-50% cell infiltration, and 3=greater than (>)50% cell infiltration); interstitial fibrosis (0=none, 1=~25% interstitial affected, 2=26-50% interstitial affected, and 3=>50% interstitial affected); tubular atrophy (0=none, 1=~15% proximal tubular atrophy [PTA], 2=16-30% PTA, and 3=>30% PTA); mesangial matrix proliferation (MMP; 0=none, 1=25% non-glomerulosclerosis [NGS] combined with moderate MMP, 2=25-50% NGS combined with MMP, and 3=>50% NGS combined with MMP); glomerular sclerosis (0=none, 1=~15% glomerulus affected, 2=16-50% glomerulus affected, and 3=>50% glomerulus affected); endothelial proliferation (EP; 0=none, 1=EP to less than (<)25% remaining artery/small artery membrane [RA/SAM], 2=EP to 26-50% [RA/SAM], and 3=>50% [RA/SAM]). CADI score was the sum of the 6 histological findings.
Measured: Month 12
Glomerular Filtration Rate (GFR) at Month 12 After Transplantation
GFR was determined using the Cockcroft-Gault formula to calculate the creatinine clearance, at Month 12 after renal transplantation. For males, creatinine clearance [milliliters per minute (mL/min)] = [(140 minus age) multiplied by (*) (body weight in kg) divided by [72 * serum creatinine mg per deciliter (mg/dL)]. For females, creatinine clearance (mL/min) = 0.85 * [(140 minus age) * (body weight in kg)] divided by [72 * serum creatinine (mg/dL)].
Measured: Month 12

Secondary outcomes (7)

Percentage of Participants Experiencing Acute Rejection, Graft Loss, or Death at 6 and 12 Months Post-Transplant
Measured: Months 6 and 12
Time to First Acute Rejection Post-Transplant - Number of Participants With an Event
Measured: BL, Weeks 2, 4, 13, 26, 39, and 52
Time to First Acute Rejection Post-Transplant
The median time, in days, between randomization and acute rejection.
Measured: BL, Weeks 2, 4, 13, 26, 39, and 52
Percentage of Participants With Treatment Failure at 12 Months Post-Transplant
Treatment failure was defined by the occurrence of any of the following: use of additional maintenance immunosuppressive medication not specified in the assigned treatment group; discontinuation of any of the assigned immunosuppressants for more than 14 consecutive days or 30 cumulative days; graft loss or return to chronic dialysis; or death.
Measured: Month 12
Participant and Graft Survival
The percentage of participants surviving with grafts intact at 6 and 12 months after renal transplant.
Measured: Months 6 and 12
Serum Creatinine (Micromoles Per Liter [µmol/L])
The mean serum creatinine values in µmol/L at Baseline (BL), Weeks 2, 4, 13, 26, 39, and 52.
Measured: BL, Weeks 2, 4, 13, 26, 39, and 52
Glomerular Filtration Rate (GFR) (mL/Min)
The mean GFR values in mL/min at BL, Weeks 2, 4, 13, 26, 39, and 52.
Measured: BL, Weeks 2, 4, 13, 26, 39, and 52

Timeline

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

Sep 2008Feb 2011

First posted25 Sep 2008 (estimated)
Study startSep 2008
Primary completionFeb 2011
Study completionFeb 2011

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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 210 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00758602
Sponsor's protocol ID: ML21740
Status last verified: Jul 2014
First submitted: 24 Sep 2008
Last updated: 4 Aug 2014
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 4 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open Label Study Comparing the Effect of CellCept Combined With Low Dose Versus Standard Dose Tacrolimus, and Corticosteroids, on Kidney Function in Renal Transplantation Patients
ClinicalTrials.gov ID: NCT00758602
Acronym / sponsor ID: ML21740
Conditions: Kidney Transplantation
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 210 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: Sep 2008
Primary completion: Feb 2011 (actual)
Study completion: Feb 2011 (actual)
First posted: 25 Sep 2008 (estimated)
Results: Posted 4 Aug 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
MMF, Standard Dose Tacrolimus	Active comparator	Drug: mycophenolate mofetil, Drug: tacrolimus, standard dose, Drug: corticosteroidsParticipants received mycophenolate mofetil (MMF) 0.75 to (-) 1 gram (g), orally (PO), twice daily (BID) from Day 0 through Month 12. Participants also received tacrolimus 0.1-0.15 milligrams per kilogram (mg/kg), PO, BID to reach a target trough dose of 8-10 nanograms per milliliter (ng/mL) from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 7-10 ng/mL in Month 3 and continued through Month 12. Participants also received corticosteroids per center practice.
MMF, Low Dose Tacrolimus	Experimental	Drug: mycophenolate mofetil, Drug: tacrolimus, low dose, Drug: corticosteroidsParticipants received MMF 0.75-1 g, PO, BID from Day 0 through Month 12. Participants also received tacrolimus 0.1-0.15 mg/kg, PO, BID to reach a target trough dose of 8-10 ng/mL from Day 0 through Month 3; the dose was adjusted to 0.05-0.08 mg/kg, PO, BID to reach a target trough dose of 2-5 ng/mL in Month 3 and continued through Month 12. Participants also received corticosteroids per center practice.

Who may qualify

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

Key inclusion criteria (3 listed)

adult patients, <=75 years of age;
single organ recipients of renal allograft;
negative pregnancy test for women of childbearing potential; reliable contraception must be used before starting drug therapy, until 6 weeks after the last dose of study medication.

Key exclusion criteria (5 listed)

severe gastrointestinal disease which may influence the absorption of oral drug therapy;
severe infection, HIV or active hepatitis;
active gastric ulcers;
malignancy other than cured skin cancer;
severe anemia, leucopenia or thrombocytopenia.

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
mycophenolate mofetilAlso: CellCept0.75-1 g PO BID from Day 0 through Month 12	Drug	MMF, Low Dose Tacrolimus, MMF, Standard Dose Tacrolimus
tacrolimus, standard doseInitial dose of 0.1-0.15 mg/kg PO BID to reach a target trough dose of 8-10 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 7-10 ng/mL in Month 3 and continued through Month 12.	Drug	MMF, Standard Dose Tacrolimus
tacrolimus, low doseInitial dose of 0.1-0.15 mg/kg PO BID to reach a target trough dose of 8 to 10 ng/mL from Day 0 through Month 3; 0.05-0.08 mg/kg PO BID to reach a target trough dose of 2-5 ng/mL in Month 3 and continued through Month 12.	Drug	MMF, Low Dose Tacrolimus
corticosteroidsAccording to center's practice	Drug	MMF, Low Dose Tacrolimus, MMF, Standard Dose Tacrolimus

Primary outcome

Chronic Allograft Damage Index (CADI) Score at Month 12 After Transplantation
Time frame: Month 12
CADI scoring was defined for 6 histological categories: interstitial inflammatory cell infiltration (0 equals (=) no or mild inflammation, 1=approximately (~)25 percent (%) cell infiltration, 2=26-50% cell infiltration, and 3=greater than (>)50% cell infiltration); interstitial fibrosis (0=none, 1=~25% interstitial affected, 2=26-50% interstitial affected, and 3=>50% interstitial affected); tubular atrophy (0=none, 1=~15% proximal tubular atrophy [PTA], 2=16-30% PTA, and 3=>30% PTA); mesangial matrix proliferation (MMP; 0=none, 1=25% non-glomerulosclerosis [NGS] combined with moderate MMP, 2=25-50% NGS combined with MMP, and 3=>50% NGS combined with MMP); glomerular sclerosis (0=none, 1=~15% glomerulus affected, 2=16-50% glomerulus affected, and 3=>50% glomerulus affected); endothelial proliferation (EP; 0=none, 1=EP to less than (<)25% remaining artery/small artery membrane [RA/SAM], 2=EP to 26-50% [RA/SAM], and 3=>50% [RA/SAM]). CADI score was the sum of the 6 histological findings.
Glomerular Filtration Rate (GFR) at Month 12 After Transplantation
Time frame: Month 12
GFR was determined using the Cockcroft-Gault formula to calculate the creatinine clearance, at Month 12 after renal transplantation. For males, creatinine clearance [milliliters per minute (mL/min)] = [(140 minus age) multiplied by (*) (body weight in kg) divided by [72 * serum creatinine mg per deciliter (mg/dL)]. For females, creatinine clearance (mL/min) = 0.85 * [(140 minus age) * (body weight in kg)] divided by [72 * serum creatinine (mg/dL)].

7 secondary outcomes

Percentage of Participants Experiencing Acute Rejection, Graft Loss, or Death at 6 and 12 Months Post-Transplant
Time frame: Months 6 and 12
Time to First Acute Rejection Post-Transplant - Number of Participants With an Event
Time frame: BL, Weeks 2, 4, 13, 26, 39, and 52
Time to First Acute Rejection Post-Transplant
Time frame: BL, Weeks 2, 4, 13, 26, 39, and 52
Percentage of Participants With Treatment Failure at 12 Months Post-Transplant
Time frame: Month 12
Participant and Graft Survival
Time frame: Months 6 and 12
Serum Creatinine (Micromoles Per Liter [µmol/L])
Time frame: BL, Weeks 2, 4, 13, 26, 39, and 52
Glomerular Filtration Rate (GFR) (mL/Min)
Time frame: BL, Weeks 2, 4, 13, 26, 39, and 52

Results and safety

Results posted to the registry on 4 Aug 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), Standard Dose Tacrolimus	104	85
MMF, Low Dose Tacrolimus	106	84

Primary outcome: Chronic Allograft Damage Index (CADI) Score at Month 12 After Transplantation

Time frame: Month 12. Mean (Standard Deviation). Unit: score on a scale

Measure	MMF, Standard Dose Tacrolimus n = 57	MMF, Low Dose Tacrolimus n = 52
Value	1.82 (1.974)	2.13 (2.000)

MMF, Standard Dose Tacrolimus vs MMF, Low Dose Tacrolimus: LS Mean difference: 0.6581 (95% CI -0.08 to 1.40), p = 0.0813, ANCOVA

Population analysed: ITT population; only participants with biopsy confirmed CADI assessment 12 months post-transplantation were included in the analysis.

Primary outcome: Glomerular Filtration Rate (GFR) at Month 12 After Transplantation

Time frame: Month 12. Mean (Standard Deviation). Unit: mL/min

Measure	MMF, Standard Dose Tacrolimus n = 86	MMF, Low Dose Tacrolimus n = 82
Value	77.08 (18.250)	80.12 (18.362)

MMF, Standard Dose Tacrolimus vs MMF, Low Dose Tacrolimus: LS Mean difference: -1.5977 (95% CI -13.77 to 10.58), p = 0.7949, ANCOVA

Population analysed: ITT population; only participants with assessable parameters for the calculation of GFR were included in the analysis.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs) were recorded from study start to 1 month after treatment completion. Treatment related serious AEs (SAEs) were reported no matter how long after the last treatment dose was administered, even though the study had been terminated.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MMF, Standard Dose Tacrolimus	1 of 104 (1%)	33 of 104 (31.7%)	Not reported
MMF, Low Dose Tacrolimus	5 of 106 (4.7%)	37 of 106 (34.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Kidney 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
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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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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

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing mycophenolate mofetil, tacrolimus, standard dose and tacrolimus, low dose in people with Kidney Transplantation, run by Hoffmann-La Roche at 6 sites in China.

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 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 4 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in China. 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 4 Aug 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?

Chronic Allograft Damage Index (CADI) Score at Month 12 After Transplantation (time frame: 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 NCT00758602.

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 4 Aug 2014.