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Renal TransplantPhase 3NCT00478608

Study Evaluating Rapamune® Maintenance Regimen

A Phase 3 study testing Sirolimus (Rapamune®) in people with Renal Transplant, run by Wyeth is now a wholly owned subsidiary of Pfizer at 9 sites in South Korea.

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

Primary : To evaluate the efficacy of sirolimus assessed by the incidence of biopsy-confirmed acute rejection episode at 6 months after transplantation in Korean renal transplantation recipients. Secondary : 1. Read more about this study

Who is it for?
Ages 13 years and older
Conditions the study is for
Renal Transplant
What is being tested?
Sirolimus (Rapamune®)
Type of treatment
Pill or oral medicine
How many people
79 participants
Where
9 sitesSouth Korea
Study dates
Mar 2007to Nov 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 13 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Age greater than or equal to 13 years of age.
  • End-stage renal disease in patients scheduled to receive a primary renal allograft from a cadaveric donor, a living-unrelated donor, or from a living-related (excluding 0 antigen mismatch) donor. A mismatch donor is defined as a donor human leukocyte antigen (HLA) antigen not shared by the patient.
  • Patients with a panel of reactive antibody (%PRA) less than or equal to 50%

Who cannot join

  • Evidence of active systemic or localized major infection at the time of initial sirolimus administration.
  • Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during pre-study screening.
  • Chronic anti-arrhythmic therapy for ventricular arrhythmia or other cardiac abnormality contraindicating general anesthesia or surgery.
  • History of malignancy within 5 years before enrollment into the study (with the exception of adequately treated basal cell or squamous cell carcinoma of the skin).
  • Current treatment with partial opioid agonists (eg, buprenorphine) or combination agonists/antagonists.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

South Korea9 sites

  • Study site

    Deagu, 700-712

  • Study site

    Deagu, 700-721

  • Study site

    Pusan, 614-735

  • Study site

    Seoul, 110-744

  • Study site

    Seoul, 120-752

  • Study site

    Seoul, 135-710

  • Study site

    Seoul, 137-701

  • Study site

    Seoul, 138-736

  • Study site

    Suwon, 443-721

Other trials in South Korea

About this study

Official title: A Clinical Study to Evaluate the Efficacy and Safety of Cyclosporine (CsA) and Sirolimus (SRL) Induction Followed by Cyclosporine Withdrawal in Korean Renal Allograft Recipients

Primary : To evaluate the efficacy of sirolimus assessed by the incidence of biopsy-confirmed acute rejection episode at 6 months after transplantation in Korean renal transplantation recipients.

Secondary :

  1. To evaluate the safety of sirolimus over 12 months after transplantation in Korean renal transplantation recipients.
  2. To evaluate graft function, patient survival and graft survival at 6 and 12 months after transplantation, and to investigate the incidence of biopsy-confirmed acute rejection episode at 12 months after transplantation.
Being tested
Sirolimus (Rapamune®)

What participants receive

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

  • Sirolimus (Rapamune®)Drug

    (1mg tablets): Initial loading dose of 6mg/day, followed by maintenance dose of 2mg/day, which was adjusted to specified trough level.

What is being measured

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

  1. Number of Patients Experiencing Biopsy Confirmed Acute Rejection Through Month 6 After Transplantation.

    The diagnosis of acute rejection required a kidney biopsy. Biopsies were assessed using the Banff criteria, standardized diagnostic categories based on histological assessments (e.g., cell types and distributions).

    Measured: 6 months after transplantation

Secondary outcomes (4)

  1. Glomerular Filtration Rate (GFR) (Nankivell Method)

    GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. For this study, GFR was calculated using the Nankivell formula. A normal GFR is >90 mL/min, although children and older people usually have a lower GFR. Lower values indicate poorer kidney function. A GFR <15 is consistent with kidney failure.

    Measured: 6 and 12 months

  2. Serum Creatinine

    Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatine, commonly found in blood, urine, and muscle tissue. It is removed from the blood by the kidneys and excreted in urine. An increased level of creatinine in the blood indicates decreased kidney function. Normal adult blood levels of creatinine are 0.5 to 1.1 mg/dL for females and 0.6 to 1.2 mg/dL for males; however, the normal values are age-dependent as elderly patients typically have smaller muscle mass.

    Measured: Baseline, 6 and 12 months

  3. Patient and Graft Survival

    Patient survival defined as patients living with or without a functioning graft. Graft survival defined as those patients who did not experience graft loss. Graft loss defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for >8 weeks), retransplant or death during the first 12 months after randomization.

    Measured: 12 months

  4. Number of Patients Experiencing Biopsy Confirmed Acute Rejection Through Month 12 After Transplantation

    The diagnosis of acute rejection required a kidney biopsy. Biopsies were assessed using the Banff criteria, standardized diagnostic categories based on histological assessments (e.g., cell types and distributions).

    Measured: 12 months after transplantation

Timeline

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

  1. First posted25 May 2007 (estimated)
  2. Study startMar 2007
  3. Primary completionNov 2008
  4. Study completionNov 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 3
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00478608
Sponsor's protocol ID
0468E-102362
Status last verified
Apr 2010
First submitted
24 May 2007
Last updated
28 Apr 2010

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sirolimus (Rapamune®) in people with Renal Transplant, run by Wyeth is now a wholly owned subsidiary of Pfizer at 9 sites in South Korea.

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

Where is the study taking place?

The record lists 9 sites in South Korea. 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 7 Jan 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?

Number of Patients Experiencing Biopsy Confirmed Acute Rejection Through Month 6 After Transplantation. (time frame: 6 months after transplantation). 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 NCT00478608.

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 28 Apr 2010.

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