NCT02554955

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2004

Longer than P75 for phase_4

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
7.8 years until next milestone

First Submitted

Initial submission to the registry

September 17, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 18, 2015

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

3.8 years

First QC Date

September 17, 2015

Last Update Submit

November 1, 2016

Conditions

Heart Transplantation

Outcome Measures

Primary Outcomes (1)

  • Percentage of participants with reported biopsy proven acute rejection episodes

    up to 6 months

Secondary Outcomes (4)

  • Incidence of adverse events

    up to 6 months

  • Incidence of Opportunistic Infections

    Up to 5 years post transplant

  • Patient and graft survival

    up to 6 months

  • Number of participants with malignancies

    up to 6 months

Study Arms (1)

Daclizumab + Mycophenolate mofetil

EXPERIMENTAL

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: DaclizumabDrug: Mycophenolate mofetilDrug: Silrolimus

Interventions

DaclizumabDRUG

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.

Also known as: Zenapax
Daclizumab + Mycophenolate mofetil
Mycophenolate mofetilDRUG

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.

Also known as: CellCept
Daclizumab + Mycophenolate mofetil
SilrolimusDRUG

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

Daclizumab + Mycophenolate mofetil

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Unknown Facility

A Coruña, 15006, Spain

Location

Unknown Facility

Barcelona, 08025, Spain

Location

Unknown Facility

Barcelona, 08036, Spain

Location

Unknown Facility

El Palmar Murcia, 30120, Spain

Location

Unknown Facility

L'Hospitalet de Llobregat, 08907, Spain

Location

Unknown Facility

Madrid, 28007, Spain

Location

Unknown Facility

Madrid, 28035, Spain

Location

Unknown Facility

Madrid, 28041, Spain

Location

Unknown Facility

Oviedo, 33006, Spain

Location

Unknown Facility

Pamplona, 31008, Spain

Location

Unknown Facility

Santander, 39008, Spain

Location

Unknown Facility

Seville, 41013, Spain

Location

Unknown Facility

Valencia, 46009, Spain

Location

Unknown Facility

Valladolid, 47005, Spain

Location

MeSH Terms

Interventions

DaclizumabMycophenolic Acid

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsCaproatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty AcidsLipids

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2015

First Posted

September 18, 2015

Study Start

February 1, 2004

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

ES(14)