Study Comparing Sirolimus With Cyclosporine in a Calcineurin Inhibitor (CNI)-Free Regimen in Kidney Transplant Recipients

NCT00137345 | Terminated Phase 3

• 2 other identifiers: 0468H1-318B1741188
• Study Type: interventional
• Target: 500
• Locations: 20 countries
• Sites: 81

Brief Summary

The purpose of this study is to determine if one drug is superior to another with regard to safety and the preservation of renal function after a kidney transplant.

Conditions

Kidney Transplant

Keywords

Randomized controlled trial; Clinical Trial Phase III; Drug therapy; Immunosuppression; Treatment outcome; Kidney transplantation; Kidney function tests

Outcome Measures

Primary Outcomes (2)

• To demonstrate the superiority of the sirolimus regimen versus cyclosporin A by intent to treat analysis of kidney function at 52 weeks, measured by mean glomerular filtration rate (GFR)

• Non-inferiority of the composite of graft loss and death at 52 weeks

Secondary Outcomes (2)

• Incidence and severity of rejection at 12, 24, 52, 104, 156, 208 weeks; GFR at 24, 104, 156, 208 weeks; progression of chronic allograft nephropathy or deterioration of transplanted kidney at 52 weeks

• quality of life at 24, 52 and 104 weeks

Interventions

sirolimus DRUG

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:

• Dialysis patients who will be receiving their first kidney transplant
• Weight over 88 pounds (lbs.)

You may not qualify if:

• Very high cholesterol levels
• Obesity
• Organ donor over 65 years of age if living; over 60 years of age if cadaveric.

Sponsors & Collaborators

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

Study Sites (82)

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San Diego, California, 92123, United States

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San Francisco, California, 94143, United States

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Denver, Colorado, 80262, United States

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New Haven, Connecticut, 06520, United States

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Gainesville, Florida, 32610, United States

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Tampa, Florida, 33606, United States

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Atlanta, Georgia, 30309, United States

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Chicago, Illinois, 60612-3824, United States

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Portland, Maine, 04102, United States

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Springfield, Massachusetts, 01199, United States

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Detroit, Michigan, 48202, United States

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New York, New York, 10029, United States

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Charlotte, North Carolina, 28203, United States

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Durham, North Carolina, 27710, United States

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Cleveland, Ohio, 44106, United States

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Cleveland, Ohio, 44195, United States

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Toledo, Ohio, 43614, United States

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Philadelphia, Pennsylvania, 19107, United States

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Philadelphia, Pennsylvania, 19129, United States

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Providence, Rhode Island, United States

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Charleston, South Carolina, 29425, United States

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Dallas, Texas, 75246, United States

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Houston, Texas, 77225, United States

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Buenos Aires, Capital Ferderal, 1093, Argentina

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Buenos Aires, Capital Ferderal, 1155, Argentina

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Buenos Aires, Capital Ferderal, 1425, Argentina

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Buenos Aires, Capital Ferderal, C1118AT, Argentina

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Buenos Aires, Capital Ferderal, C1425APQ, Argentina

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Buenos Aires, CP1900, Argentina

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Ciudad de Bs As, Argentina

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Córdoba, 5000, Argentina

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Córdoba, Argentina

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Camperdown, NSW 2050, Australia

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Parkville, 3050, Australia

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Randwick, 2031, Australia

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Westmead, 2145, Australia

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Woodville South, SA 5011, Australia

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Woolloongabba, QLD 4102, Australia

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Vienna, A-1090, Austria

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London, Ontario, N6A 5A5, Canada

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Cote Du Palais, Quebec, G1R 2J6, Canada

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Montreal, Quebec, H2L 4M1, Canada

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Puente Alto, Chile

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Santiago, Chile

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Talca, Chile

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Viña del Mar, Chile

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Nicosia, 1102, Cyprus

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Montpellier, 34059, France

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Paris, 75747, France

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Münster, 48149, Germany

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Athens, 11527, Greece

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Thessaloniki, 54642, Greece

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Budapest, 1083, Hungary

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Debrecen, 4012, Hungary

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Pécs, 7621, Hungary

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Szeged, 6720, Hungary

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Bari, 70124, Italy

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Cagliari, 09134, Italy

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Torino, 10126, Italy

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Oslo, 0027, Norway

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Carnaxide-lisboa, 2795-563, Portugal

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Coimbra, 3049, Portugal

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Lisbon, 81050, Portugal

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Singapore, 169608, Singapore

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Cape Town, 7925, South Africa

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Cape Town, 8001, South Africa

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Johannesburg, 2193, South Africa

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Barcelona, 08036, Spain

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La Coruã'a, 15006, Spain

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La Laguna / Santa Cruz de Tenerife, 38320, Spain

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Madrid, 28040, Spain

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Madrid, 28041, Spain

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Santander, 39008, Spain

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Valencia, 46009, Spain

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Uppsala, SE-751 85, Sweden

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Taipei, 100, Taiwan

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Antalya, 07070, Turkey (Türkiye)

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Istanbul, 34390, Turkey (Türkiye)

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Izmir, 35100, Turkey (Türkiye)

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Glasgow, G11 6NT, United Kingdom

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Leicester, LE5 4PW, United Kingdom

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Manchester, M13 9WL, United Kingdom

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Related Publications (1)

• Flechner SM, Gurkan A, Hartmann A, Legendre CM, Russ GR, Campistol JM, Schena FP, Hahn CM, Li H, Korth-Bradley JM, Tai SS, Schulman SL. A randomized, open-label study of sirolimus versus cyclosporine in primary de novo renal allograft recipients. Transplantation. 2013 May 27;95(10):1233-41. doi: 10.1097/TP.0b013e318291a269.

  PMID: 23689085 DERIVED

MeSH Terms

Interventions

Sirolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Medical Monitor

  Wyeth is now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

• Trial Manager

  For Germany, MedInfoDEU@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Norway, Sweden, MedInfoNord@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Australia, Taiwan, medinfo@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Austria, WPVIMED@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Italy, Greece, decresg@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial manager

  For Hungary, WPBUMED@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Turkey, Erisc@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For South Africa, ZAFinfo@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Argentina, Chile, scheima@wyeth.com, rendop@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For UK, ukmedonfo@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Switzerland, med@wyeth.com

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 25, 2005
• First Posted: August 29, 2005
• Study Start: June 1, 2005
• Primary Completion: August 1, 2006
• Study Completion: August 1, 2006
• Last Updated: February 8, 2013

Record last verified: 2006-09

Locations

SE (1); TW (1); GB (3); FR (2); ES (7); TU (3); ZA (3); SG (1); DE (1); HU (4); AU (6); US (23); AR (9); CY (1); IT (3); CA (3); GR (2); NO (1); PT (3); CL (4)