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Rochester, New York 14642

  • Liver Transplantation

Purpose:

The purpose of this study is to evaluate the sirolimus conversion regimen as compared with the calcineurin inhibitor continuation regimen with regards to renal function in stable liver transplant subjects.


Criteria:

Inclusion Criteria: - Age greater than 13 years (age greater than 18 years as required by some local regulations). - Receiving immunosuppressive therapy with calcineurin inhibitors (CI) +/- corticosteroids +/- antimetabolite. - 6 to 144 months after orthotopic liver transplantation. - Cockcroft-Gault GFR values ≥40 mL/min and ≤90mL/min at screening Exclusion Criteria: - History of nonhepatic transplantation - Evidence of systemic infection (sepsis, bacteremia, pneumonia etc). - Known or suspected malignancy < 5 years before random assignment.


Study is Available At:


Original ID:

0468H1-313


NCT ID:

NCT00086346


Secondary ID:


Study Acronym:


Brief Title:

Study Evaluating of Calcineurin Inhibitor and Sirolimus (Rapamune) Treatment in Liver Transplant Recipients


Official Title:

A Randomized, Open-Label, Comparative Evaluation of Conversion From Calcineurin Inhibitor Treatment to Sirolimus Treatment Versus Continued Calcineurin Inhibitor Treatment in Liver Allograft Recipients Undergoing Maintenance Therapy


Overall Status:

Terminated


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

13 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Wyeth


Oversight Authority:

  • Belgium: Federal Agency for Medicines and Health Products, FAMHP
  • Czech Republic: State Institute for Drug Control
  • France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
  • Germany: Paul-Ehrlich-Institut
  • Italy: Ministry of Health
  • Netherlands: Medicines Evaluation Board (MEB)
  • Portugal: National Pharmacy and Medicines Institute
  • Spain: Ministry of Health
  • Switzerland: Swissmedic
  • United Kingdom: Medicines and Healthcare Products Regulatory Agency
  • United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

607


Enrollment Type:

Actual


Overall Contact Information

Official Name:Medical Monitor
Study Director
Wyeth

Study Dates

Start Date:December 2002
Completion Date:July 2008
Completion Type:Actual
Primary Completion Date:July 2008
Primary Completion Type:Actual
Verification Date:April 2010
Last Changed Date:April 20, 2010
First Received Date:June 30, 2004
First Results Date:July 6, 2009

Study Outcomes

Outcome Type:Primary Outcome
Measure:Change From Baseline Adjusted Mean in Glomerular Filtration Rate (GFR)
Time Frame:Baseline and 12 months
Safety Issues:False
Description:GFR is an index of kidney function. GFR was calculated using Cockcroft-Gault method. A normal GFR is >90 mL/min, higher values indicate better function. Change=adjusted mean of 12 months minus baseline. Mean adjusted for baseline GFR, with antimeta
Outcome Type:Primary Outcome
Measure:Patient and Graft Survival
Time Frame:12 months
Safety Issues:True
Description:Endpoint was a composite assessment of patient and graft survival. Patients categorized as graft survival or graft loss. Graft loss defined as pure graft loss (requiring retransplant) or death (with a functioning graft), if the event occurred in the fir
Outcome Type:Secondary Outcome
Measure:Number of Patients With a Biopsy Confirmed Acute Rejection
Time Frame:12 months
Safety Issues:True
Description:Overall event rate is determined as yes or no.
Outcome Type:Secondary Outcome
Measure:Mean Serum Creatinine
Time Frame:12 months
Safety Issues:False
Description:Observed mean values for serum creatinine.

Study Interventions

Intervention Type:Drug
Name:Sirolimus (Rapamune)
Arm Name:A
Intervention Type:Drug
Name:Cyclosporine or Tacrolimus
Arm Name:B

Study Arms

Study Arm Type:Active Comparator
Arm Name:A
Study Arm Type:Active Comparator
Arm Name:B

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Wyeth

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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