AzTrials
AzTrials

Liver TransplantationPhase 4NCT00118742

Liver Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Sirolimus in Recipients of a Liver Transplant

A Phase 4 study testing mycophenolate mofetil [CellCept], Tacrolimus and Cyclosporine in people with Liver Transplantation, run by Hoffmann-La Roche at 46 sites in 2 countries.

Completed

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

Official record
Search all trials

Trial summary

This two-arm study will assess the efficacy and safety of a long-term calcineurin inhibitor-free maintenance regimen with CellCept and sirolimus in recipients of an orthotropic liver transplant. Read more about this study

Who is it for?
Ages 18 to 74 years
Conditions the study is for
Liver Transplantation
What is being tested?
mycophenolate mofetil [CellCept], Tacrolimus and Cyclosporine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
293 participants
Where
46 sitesin 2 countries
Study dates
Aug 2005to Dec 2008
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 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patients 18-74 years of age
  • Single primary liver transplant from a deceased donor
  • CellCept plus tacrolimus or cyclosporine from time of transplantation (within 72 hours)
  • Patients with hepatitis C-positive status may be entered if they have had an intraoperative (back table) biopsy of the transplanted liver or will have a biopsy at the time of randomization. This is not required for patients negative for hepatitis C.

Who cannot join

  • Liver allograft from a living donor or a split liver
  • Multiple organ transplant
  • Dialysis therapy for >14 days from transplantation to randomization
  • History of malignancy in the last 5 years (except hepatoma or non-melanoma skin cancer)
  • Previous sirolimus therapy

Trial locations and contacts

46 sites in 2 countries.

46 sites in 2 countries

United States41 sites

  • Study site

    Atlanta, Georgia, 30322

  • Study site

    Baltimore, Maryland, 21201

  • Study site

    Birmingham, Alabama, 35294

  • Study site

    Boston, Massachusetts, 02111

  • Study site

    Boston, Massachusetts, 02114-2696

  • Study site

    Boston, Massachusetts, 02215

  • Study site

    Burlington, Massachusetts, 01805

  • Study site

    Chapel Hill, North Carolina, 27599

  • Study site

    Chicago, Illinois, 60611

  • Study site

    Chicago, Illinois, 60612-3824

  • Study site

    Cleveland, Ohio, 44195

  • Study site

    Dallas, Texas, 75246

  • Study site

    Denver, Colorado, 80262

  • Study site

    Detroit, Michigan, 48202-2689

  • Study site

    Hawthorne, New York, 10532

  • Study site

    Houston, Texas, 77030

  • Study site

    Jacksonville, Florida, 32216

  • Study site

    La Jolla, California, 92037

  • Study site

    Los Angeles, California, 90033-4612

  • Study site

    Los Angeles, California, 90095

  • Study site

    Madison, Wisconsin, 53792

  • Study site

    Miami, Florida, 33136

  • Study site

    Minneapolis, Minnesota, 55455

  • Study site

    Nashville, Tennessee, 37232

  • Study site

    New Orleans, Louisiana, 70121

  • Study site

    New York, New York, 10016

  • Study site

    New York, New York, 10029

  • Study site

    New York, New York, 10032

  • Study site

    Newark, New Jersey, 07101-1709

  • Study site

    Oklahoma City, Oklahoma, 73112-4481

  • Study site

    Philadelphia, Pennsylvania, 19141

  • Study site

    Phoenix, Arizona, 85054

  • Study site

    Portland, Oregon, 97201-3098

  • Study site

    Richmond, Virginia, 23298

  • Study site

    Rochester, Minnesota, 55905

  • Study site

    San Antonio, Texas, 78284

  • Study site

    San Diego, California, 92103-8401

  • Study site

    San Francisco, California, 94115

  • Study site

    San Francisco, California, 94143-0780

  • Study site

    St Louis, Missouri, 63110

  • Study site

    Tampa, Florida, 33606

Other trials in United States

Canada5 sites

  • Study site

    Edmonton, Alberta, T6G 2B7

  • Study site

    Halifax, Nova Scotia, B3H 3A7

  • Study site

    London, Ontario, N6A 5A5

  • Study site

    Montreal, Quebec, H2X 3J4

  • Study site

    Montreal, Quebec, H3A 1A1

Other trials in Canada

About this study

Official title: A Randomized, Open-label Study of the Effect of a Long-term Calcineurin Inhibitor-free Maintenance Regimen With CellCept and Sirolimus on Preservation of Renal Function and Prevention of Acute Rejection in Recipients of an Orthotropic Liver Transplant

This two-arm study will assess the efficacy and safety of a long-term calcineurin inhibitor-free maintenance regimen with CellCept and sirolimus in recipients of an orthotropic liver transplant. Patients will be randomized to receive either CellCept 1-1.5 g twice daily (BID) + tacrolimus + cyclosporine, or CellCept 1-1.5 g BID + sirolimus. The anticipated time on study treatment is 1 to 2 years, and the target sample size is 100 to 500 individuals.

Being tested
mycophenolate mofetil [CellCept], Tacrolimus, Cyclosporine, Sirolimus

What participants receive

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

  • mycophenolate mofetil [CellCept]Drug

    1-1.5 g orally or intravenously twice daily

  • TacrolimusDrug

    As prescribed, for 12 months

  • CyclosporineDrug

    As prescribed, for 12 months

  • SirolimusDrug

    2-4 mg orally once daily for 9-11 months

Study groups in NCT00118742
Study groupRoleWhat they receive
CellCept + CNI (tacrolimus or cyclosporine)ExperimentalNot described
Receives: Drug: mycophenolate mofetil [CellCept]; Drug: Tacrolimus; Drug: Cyclosporine
CellCept + sirolimusActive comparatorNot described
Receives: Drug: mycophenolate mofetil [CellCept]; Drug: Sirolimus

What is being measured

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

  1. Change From Baseline in Glomerular Filtration Rate (GFR) at 12 Months Posttransplant

    Mean percent change from baseline in estimated glomerular filtration rate (GFR) calculated by modification of diet in renal disease (MDRD)-6 variable equation at 12 months posttransplantation. MDRD-6 variables: serum creatinine, albumin and urea nitrogen, gender, age and ethnicity.

    Measured: 12 months posttransplant

Secondary outcomes (3)

  1. Change From Baseline in Glomerular Filtration Rate (GFR) at 6 Months Posttransplant

    Mean percent change from baseline in estimated GFR calculated by modification of diet in renal disease (MDRD)-6 variable equation at 6 and 24 months posttransplantation. MDRD-6 variables: serum creatinine, albumin and urea nitrogen, gender, age and ethnicity.

    Measured: 6 months posttransplant

  2. Change From Baseline in Glomerular Filtration Rate (GFR) at 24 Months Posttransplant

    Mean percent change from baseline in estimated GFR calculated by modification of diet in renal disease (MDRD)-6 variable equation at 6 and 24 months posttransplantation. MDRD-6 variables: serum creatinine, albumin and urea nitrogen, gender, age and ethnicity.

    Measured: 24 months posttransplant

  3. Change From Baseline in Creatinine Clearance

    Mean percent change from baseline in calculated creatinine clearance (CL) at 6, 12, and 24 months posttransplantation

    Measured: 6, 12, and 24 months posttransplantation

Timeline

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

  1. First posted12 Jul 2005 (estimated)
  2. Study startAug 2005
  3. Primary completionJul 2008
  4. Study completionDec 2008

Resources

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
293 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00118742
Sponsor's protocol ID
ML18423
Status last verified
Jul 2010
First submitted
30 Jun 2005
Last updated
3 Aug 2010

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing mycophenolate mofetil [CellCept], Tacrolimus and Cyclosporine in people with Liver Transplantation, run by Hoffmann-La Roche at 46 sites in 2 countries.

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 3 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in United States, Canada. 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 Mar 2010). 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 From Baseline in Glomerular Filtration Rate (GFR) at 12 Months Posttransplant (time frame: 12 months posttransplant). 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 NCT00118742.

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 3 Aug 2010.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in