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

NCT00086346 | Terminated Phase 3 Results DMC

• 1 other identifier: 0468H1-313
• Study Type: interventional
• Target: 607
• Locations: 12 countries
• Sites: 42

Brief Summary

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.

Conditions

Liver Transplantation

Keywords

Liver; Transplant

Outcome Measures

Primary Outcomes (2)

• Change From Baseline Adjusted Mean in Glomerular Filtration Rate (GFR)

  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 antimetabolite therapy status and hepatitis C status as fixed effects.

  Baseline and 12 months

• Patient and Graft Survival

  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 first 12 months after randomization. Patients with missing graft data were counted as graft losses.

  12 months

Secondary Outcomes (2)

• Number of Patients With a Biopsy Confirmed Acute Rejection

  12 months

• Mean Serum Creatinine

  12 months

Study Arms (2)

A

ACTIVE COMPARATOR

Drug: Sirolimus (Rapamune)

B

ACTIVE COMPARATOR

Drug: Cyclosporine or Tacrolimus

Interventions

Sirolimus (Rapamune) DRUG

A

Cyclosporine or Tacrolimus DRUG

B

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• to 144 months after orthotopic liver transplantation.
• Cockcroft-Gault GFR values ≥40 mL/min and ≤90mL/min at screening

You may not qualify if:

• History of nonhepatic transplantation
• Evidence of systemic infection (sepsis, bacteremia, pneumonia etc).
• Known or suspected malignancy \< 5 years before random assignment.

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

Study Sites (42)

Unknown Facility

San Francisco, California, 94143-0780, United States

Location

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Tampa, Florida, 33606, United States

Location

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New Orleans, Louisiana, 70121, United States

Location

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Detroit, Michigan, 48202, United States

Location

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Rochester, Minnesota, 55905, United States

Location

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Omaha, Nebraska, 68198-3285, United States

Location

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New York, New York, 10029, United States

Location

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Rochester, New York, 14642-8410, United States

Location

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Cleveland, Ohio, 44195, United States

Location

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Philadelphia, Pennsylvania, 19104, United States

Location

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Ghent, 9000, Belgium

Location

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Edmonton, Alberta, T6G 2B7, Canada

Location

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London, Ontario, N6A 5A5, Canada

Location

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Toronto, Ontario, M5G 2C4, Canada

Location

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Prague, 14021, Czechia

Location

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Clichy, 92118, France

Location

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Lyon, 69437, France

Location

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Nice, 06200, France

Location

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Paris, 75679, France

Location

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Rennes, 35033, France

Location

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Villejuif, 94800, France

Location

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Berlin, 13353, Germany

Location

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Hamburg, 20251, Germany

Location

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München, 81377, Germany

Location

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Bologna, Italy

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Milan, 20122, Italy

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Padua, 35128, Italy

Location

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Leiden, 2300, Netherlands

Location

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Coimbra, 3049, Portugal

Location

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Lisbon, 1069-166, Portugal

Location

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Barcelona, 08035, Spain

Location

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Barcelona, 08036, Spain

Location

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Barcelona, 08907, Spain

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Madrid, 28034, Spain

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Pamplona, 31008, Spain

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Santiago de Compostela, 15706, Spain

Location

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Valencia, 46009, Spain

Location

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Bern, CH-3010, Switzerland

Location

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Zurich, CH-8091, Switzerland

Location

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Birmingham, B15 2TH, United Kingdom

Location

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Edinburgh, EH16 4SA, United Kingdom

Location

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Leeds, LS9 7TF, United Kingdom

Location

MeSH Terms

Interventions

Sirolimus; Cyclosporine; Tacrolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: U. S. Contact Center
• Organization: Wyeth

clintrialresults@wyeth.com

Study Officials

• Medical Monitor

  Wyeth is now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

• Trial Manager

  For Italy, decresg@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Germany, MedInfoDEU@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Belgium, trials-BEL@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Czech Republic, WPPGCLI@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Netherlands, trials-NL@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Switzerland, med@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For UK, ukmedinfo@wyeth.com

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 30, 2004
• First Posted: July 2, 2004
• Study Start: December 1, 2002
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: April 28, 2010
• Results First Posted: September 7, 2009

Record last verified: 2010-04

Locations

NL (1); CA (3); IT (3); CZ (1); US (10); BE (1); DE (3); CH (2); FR (6); PT (2); GB (3); ES (7)