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AzTrials

Kidney TransplantationPhase 4NCT00121810

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

A Phase 4 study testing mycophenolate mofetil [CellCept], Corticosteroids and Calcineurin inhibitors in people with Kidney Transplantation, run by Hoffmann-La Roche at 36 sites in United States.

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 2-arm study recruited kidney transplant patients who were receiving standard care of calcineurin inhibitors (CNIs, tacrolimus or cyclosporine), CellCept (1.0-1.5 g twice daily) and corticosteroids. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Kidney Transplantation
What is being tested?
mycophenolate mofetil [CellCept], Corticosteroids and Calcineurin inhibitors
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
305 participants
Where
36 sitesUnited States
Study dates
Aug 2003to Nov 2009
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patients 18-75 years of age
  • Kidney transplant 30-180 days post-transplantation
  • Receipt of cyclosporine or tacrolimus, CellCept, and corticosteroids for greater than 14 days prior to study entry
  • No known contraindications to sirolimus

Who cannot join

  • Multiple organ transplant recipients or secondary kidney transplant recipients
  • Corticosteroid-resistant rejection episode within 90 days prior to study entry or corticosteroid-sensitive rejection episode within 30 days prior to study entry
  • More than 1 biopsy-proven episode of acute rejection prior to study entry
  • Treated with sirolimus before the study
  • Organ transplant or expected organ transplant, other than kidney
  • History of malignancy in the last 5 years (except successfully treated localized non-melanotic skin cancer)

Trial locations and contacts

36 sites in 1 country.

36 sites in 1 country

United States36 sites

  • Study site

    Atlanta, Georgia, 30322

  • Study site

    Bakersfield, California, 93309

  • Study site

    Baltimore, Maryland, 21201

  • Study site

    Boston, Massachusetts, 02114-2696

  • Study site

    Camden, New Jersey, 08103

  • Study site

    Charleston, South Carolina, 29425

  • Study site

    Charlottesville, Virginia, 22908

  • Study site

    Cincinnati, Ohio, 45267-0558

  • Study site

    Dallas, Texas, 75246

  • Study site

    Denver, Colorado, 80262

  • Study site

    Detroit, Michigan, 48202-2689

  • Study site

    Durham, North Carolina, 27710

  • Study site

    Galveston, Texas, 77555

  • Study site

    Hartford, Connecticut, 06106-3316

  • Study site

    Indianapolis, Indiana, 46202-5124

  • Study site

    Indianapolis, Indiana, 46202

  • Study site

    Iowa City, Iowa, 52242

  • Study site

    Lexington, Kentucky, 40536-0293

  • Study site

    Livingston, New Jersey, 07039

  • Study site

    Los Angeles, California, 90033

  • Study site

    Los Angeles, California, 90057

  • Study site

    Maywood, Illinois, 60153

  • Study site

    Memphis, Tennessee, 38104

  • Study site

    Nashville, Tennessee, 37232

  • Study site

    New Orleans, Louisiana, 70112

  • Study site

    New York, New York, 10029

  • Study site

    New York, New York, 10032

  • Study site

    Palo Alto, California, 94304-1509

  • Study site

    Philadelphia, Pennsylvania, 19107

  • Study site

    Portland, Oregon, 97201

  • Study site

    Riverside, California, 92501

  • Study site

    San Antonio, Texas, 78284

  • Study site

    San Diego, California, 92123

  • Study site

    San Francisco, California, 94115

  • Study site

    Sioux Falls, South Dakota, 57105

  • Study site

    Washington D.C., District of Columbia, 20010-2975

Other trials in United States

About this study

Official title: An Open Label, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of Early Calcineurin Inhibitor Withdrawal in Recipients of Primary Renal Allografts Maintained Long-term on Mycophenolate Mofetil (MMF) (CellCept®) and Sirolimus (Rapamune®)

This 2-arm study recruited kidney transplant patients who were receiving standard care of calcineurin inhibitors (CNIs, tacrolimus or cyclosporine), CellCept (1.0-1.5 g twice daily) and corticosteroids. They were either randomized to continue this regimen, or CNI therapy was discontinued and replaced by sirolimus therapy (in combination with CellCept and corticosteroids). The effect of these 2 regimens on efficacy, safety and kidney function was evaluated. The anticipated time on study treatment was 1-2 years, and the target sample size was 100-500 individuals.

Being tested
mycophenolate mofetil [CellCept], Corticosteroids, Calcineurin inhibitors, Sirolimus

What participants receive

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

  • mycophenolate mofetil [CellCept]Drug

    1.0-1.5 g oral dose twice daily

  • CorticosteroidsDrug

    As prescribed

  • Calcineurin inhibitorsDrug

    As prescribed

  • SirolimusDrug

    As prescribed

Study groups in NCT00121810
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: mycophenolate mofetil [CellCept]; Drug: Corticosteroids; Drug: Sirolimus
2Active comparatorNot described
Receives: Drug: mycophenolate mofetil [CellCept]; Drug: Corticosteroids; Drug: Calcineurin inhibitors

What is being measured

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

  1. Mean Percent Change in Glomerular Filtration Rate From Baseline to Month 12

    The primary efficacy endpoint was mean percent change in renal function from baseline to 12 months postrandomization, as measured by Glomerular Filtration Rate utilizing renal clearance of cold iothalamate.

    percent change= [(Glomerular Filtration Rate at Month 12-Glomerular Filtration Rate at baseline)/Glomerular Filtration Rate at baseline]*100 percent.

    Measured: baseline to 12 months

Secondary outcomes (4)

  1. Mean Percent Change in Glomerular Filtration Rate From Baseline to Month 24

    A secondary efficacy endpoint was mean percent change in renal function from baseline to 24 months postrandomization, as measured by Glomerular Filtration Rate utilizing renal clearance of cold iothalamate.

    percent change= [(Glomerular Filtration Rate at Month 24-Glomerular Filtration Rate at baseline)/Glomerular Filtration Rate at baseline]*100 percent.

    Measured: Baseline to 24 months

  2. Mean Percent Change in Serum Creatinine From Baseline to Months 6, 12, and 24

    Renal allograft function determined by mean percent change from baseline in serum creatinine by treatment group at 6, 12, and 24 months postrandomization.

    percent change= [(serum creatinine at Month t-serum creatinine at baseline)/serum creatinine at baseline]*100 percent, where t=6, 12, and 24 months postrandomization.

    Measured: baseline, 6, 12, and 24 months

  3. Mean Percent Change in Calculated Creatinine Clearance From Baseline to Months 6, 12, and 24

    Renal allograft function determined by mean percent change from baseline in calculated creatinine clearance (Cockroft and Gault method) by treatment group at 6, 12, and 24 months postrandomization.

    percent change= [(calculated creatinine clearance at Month t - calculated creatinine clearance at baseline)/calculated creatinine clearance at baseline]*100 percent, where t=6, 12, and 24 months postrandomization

    Measured: baseline 6, 12, and 24 months

  4. Mean Percent Change in Calculated Glomerular Filtration Rate From Baseline to Months 6, 12, and 24 (Nankivell Equation)

    Renal allograft function determined by mean percent change from baseline in calculated Glomerular Filtration Rate (Nankivell equation) by treatment group at 6, 12, and 24 months postrandomization.

    percent change= [(calculated Glomerular Filtration Rate at Month t - calculated Glomerular Filtration Rate at baseline)/calculated Glomerular Filtration Rate at baseline]*100 percent, where t=6, 12, and 24 months postrandomization.

    Measured: baseline, 6, 12, and 24 months

Timeline

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

  1. First posted21 Jul 2005 (estimated)
  2. Study startAug 2003
  3. Primary completionNov 2009
  4. Study completionNov 2009

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
305 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00121810
Sponsor's protocol ID
ML17140
Status last verified
Apr 2011
First submitted
15 Jul 2005
Last updated
15 Apr 2011

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing mycophenolate mofetil [CellCept], Corticosteroids and Calcineurin inhibitors in people with Kidney Transplantation, run by Hoffmann-La Roche at 36 sites in United States.

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 6 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 15 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in United States. 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 24 Feb 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?

Mean Percent Change in Glomerular Filtration Rate From Baseline to Month 12 (time frame: baseline to 12 months). 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 NCT00121810.

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 15 Apr 2011.

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