A Study to Assess Use of Zenapax (Daclizumab) and CellCept (Mycophenolate Mofetil) to Improve Kidney Function in Kidney Transplant Patients

NCT00048152 | Completed Phase 3

• 1 other identifier: M67005
• Study Type: interventional
• Target: 539
• Locations: 12 countries
• Sites: 36

Brief Summary

This study will compare kidney function in kidney transplant patients following treatment with various combinations of Zenapax, CellCept, corticosteroids, and Neoral (Cyclosporine). The anticipated time on study treatment is 6-12 months, and the target sample size is 500+ individuals.

Conditions

Kidney Transplantation

Outcome Measures

Primary Outcomes (1)

• Renal function (as measured by GFR)

  12 months post-transplant

Secondary Outcomes (3)

• Patient and graft survival \n

  12 months post-transplant

• Proportion of patients with biopsy-proven rejection; treatment failure.

  6 and 12 months post-transplant

• AEs, OIs, malignancies, deaths

  Throughout study

Study Arms (3)

1

EXPERIMENTAL

Drug: Corticosteroids; Drug: Neoral; Drug: Zenapax; Drug: mycophenolate mofetil [CellCept]

2

EXPERIMENTAL

Drug: Corticosteroids; Drug: Neoral; Drug: Zenapax; Drug: mycophenolate mofetil [CellCept]

3

EXPERIMENTAL

Drug: Corticosteroids; Drug: Neoral; Drug: mycophenolate mofetil [CellCept]

Interventions

Corticosteroids DRUG

As prescribed

1; 2; 3

Neoral DRUG

Low dose (target trough level 50-100ng/mL)

1; 2

Zenapax DRUG

2mg/kg iv first dose, then 1mg/kg every 2 weeks

1; 2

mycophenolate mofetil [CellCept] DRUG

1g po bid

1; 2; 3

Eligibility Criteria

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

You may qualify if:

• adult patients greater than 18 years of age
• recipients of primary kidney transplant
• single-organ recipients (kidney only)

You may not qualify if:

• previous treatment with Zenapax
• history of malignancy (except localized skin cancer)

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (36)

Unknown Facility

Birmingham, Alabama, 35294, United States

Location

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San Francisco, California, 94143, United States

Location

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Gainesville, Florida, 32610, United States

Location

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Atlanta, Georgia, 30322, United States

Location

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Livingston, New Jersey, 07039, United States

Location

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Philadelphia, Pennsylvania, 19102-1192, United States

Location

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Charleston, South Carolina, 29425-0777, United States

Location

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Falls Church, Virginia, 22042-3300, United States

Location

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Adelaide, 5011, Australia

Location

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Sydney, 2050, Australia

Location

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Brussels, 1070, Belgium

Location

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Leuven, 3000, Belgium

Location

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Calgary, Alberta, T2N 2T9, Canada

Location

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Edmonton, Alberta, T6G 2R8, Canada

Location

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Vancouver, British Columbia, V6Z 1Y6, Canada

Location

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Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

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Vandœuvre-lès-Nancy, 54511, France

Location

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Berlin, 13353, Germany

Location

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Hanover, 30625, Germany

Location

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Münster, 48149, Germany

Location

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Mexico City, 06720, Mexico

Location

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Monterrey, 06720, Mexico

Location

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Oslo, 0027, Norway

Location

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Warsaw, 02-006, Poland

Location

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Wroclaw, 50-417, Poland

Location

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Barcelona, 08036, Spain

Location

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Barcelona, 08907, Spain

Location

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Córdoba, 14004, Spain

Location

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Málaga, 29010, Spain

Location

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Santander, 39008, Spain

Location

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Valencia, 46009, Spain

Location

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Gothenburg, 41345, Sweden

Location

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Malmo, 20502, Sweden

Location

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Birmingham, B15 2TH, United Kingdom

Location

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Glasgow, G11 6NT, United Kingdom

Location

Unknown Facility

Leicester, LE5 4PW, United Kingdom

Location

MeSH Terms

Interventions

Adrenal Cortex Hormones; Cyclosporine; Daclizumab; Mycophenolic Acid

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

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: October 24, 2002
• First Posted: October 25, 2002
• Study Start: December 1, 2000
• Primary Completion: March 1, 2006
• Study Completion: March 1, 2006
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

GB (3); PL (2); NO (1); ME (2); AU (2); US (8); BE (2); CA (4); FR (1); ES (6); SE (2); DE (3)