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Trial record 79 of 1164 for:    MYCOPHENOLIC ACID

A Study of Daclizumab (Zenapax) in Combination With Mycophenolate Mofetil (CellCept) and Sirolimus in Prevention of Acute Rejection in Heart Transplant Participants

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ClinicalTrials.gov Identifier: NCT02554955
Recruitment Status : Completed
First Posted : September 18, 2015
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This study will evaluate the efficacy and safety of intravenous daclizumab in combination with oral mycophenolate mofetil and oral sirolimus in participants receiving a heart transplant, and at risk of impaired kidney function. The anticipated time on study treatment is 6 months, and the target sample size is 44 individuals.

Condition or disease Intervention/treatment Phase
Heart Transplantation Drug: Daclizumab Drug: Mycophenolate mofetil Drug: Silrolimus Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot, Single-arm, Non-comparative, Open-label Study of Daclizumab in Combination With Mycophenolate Mofetil and Sirolimus in the Prevention of Acute Rejection in Cardiac Allografts Recipients in Risk of Deteriorated Renal Function
Study Start Date : February 2004
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007


Arm Intervention/treatment
Experimental: Daclizumab + Mycophenolate mofetil
Participants will receive intravenous (IV) daclizumab (2 milligrams per kilogram [mg/kg] within 6 hours after transplantation and 1 mg/kg every 2 weeks for a total of five doses), along with mycophenolate mofetil (one dose of 1.5 mg within 12 hours pretransplant, 1.5 mg twice daily [BID] within first week and 1 grams per day [g/day] BID from second week onwards) and sirolimus (3 mg/day) for 6 months.
Drug: Daclizumab
Participants will receive IV daclizumab (2 mg/kg within 6 hours after transplantation and 1 mg/kg every 2 weeks) for a total of five doses.
Other Name: Zenapax

Drug: Mycophenolate mofetil
Participants will receive mycophenolate mofetil orally (one dose of 1.5 mg within 12 hours pretransplant, 1.5 mg BID within first week and 1 g/day BID from second week onwards) for 6 months.
Other Name: CellCept

Drug: Silrolimus
Participants will receive sirolimus orally (3 mg/day) for 6 months.




Primary Outcome Measures :
  1. Percentage of participants with reported biopsy proven acute rejection episodes [ Time Frame: up to 6 months ]

Secondary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: up to 6 months ]
  2. Incidence of Opportunistic Infections [ Time Frame: Up to 5 years post transplant ]
  3. Patient and graft survival [ Time Frame: up to 6 months ]
  4. Number of participants with malignancies [ Time Frame: up to 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult participants greater than 18 years of age
  • Single organ (heart) transplant recipients
  • At risk for post-transplant renal dysfunction

Exclusion Criteria:

  • Previous organ transplant
  • Previous treatment with mycophenolate mofetil, daclizumab or sirolimus
  • Positive for human immunodeficiency virus (HIV) infection
  • History of malignancy within the last 5 years, except localized and treated skin cancer, treated and without evident relapse

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02554955


Locations
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Spain
Barcelona, Spain, 08025
Barcelona, Spain, 08036
El Palmar Murcia, Spain, 30120
Hospitalet de Llobregat, Spain, 08907
La Coruna, Spain, 15006
Madrid, Spain, 28007
Madrid, Spain, 28035
Madrid, Spain, 28041
Oviedo, Spain, 33006
Pamplona, Spain, 31008
Santander, Spain, 39008
Sevilla, Spain, 41013
Valencia, Spain, 46009
Valladolid, Spain, 47005
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Chair: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02554955     History of Changes
Other Study ID Numbers: ML17910
First Posted: September 18, 2015    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
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Mycophenolic Acid
Sirolimus
Everolimus
Daclizumab
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antitubercular
Antitubercular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action