NCT00195273

Brief Summary

The purpose of this study is to compare the kidney function in patients who have received a transplanted kidney and were treated with the combination of sirolimus, daclizumab, mycophenolate and corticosteroids versus transplanted patients treated with cyclosporine, mycophenolate and corticosteroids.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2004

Typical duration for phase_3

Geographic Reach
2 countries

3 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

November 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

September 7, 2009

Completed
Last Updated

April 28, 2010

Status Verified

April 1, 2010

Enrollment Period

3.7 years

First QC Date

September 12, 2005

Results QC Date

July 31, 2009

Last Update Submit

April 22, 2010

Conditions

Graft vs Host DiseaseKidney Transplantation

Keywords

KidneyTransplant

Outcome Measures

Primary Outcomes (1)

  • Mean Creatinine Clearance Rate

    Creatinine clearance is a measure of kidney function. Creatinine clearance rate is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Creatinine clearance can be measured directly or estimated using established formulas. For this study, the creatinine clearance rate was calculated using the Nankivell formula. Normal values for healthy, young males are in the range of 100-135 ml/min and for females 90-125 ml/min. A low creatinine clearance indicates poor kidney function.

    12 months

Secondary Outcomes (3)

  • Number of Patients With Acute Rejection

    3 and 12 months

  • Patient and Graft Survival

    12 months

  • Mean Creatinine Clearance Rate - 3 Months

    3 months

Study Arms (2)

1

EXPERIMENTAL

Sirolimus + Daclizumab + Mycophenolate + Corticosteroids

Drug: sirolimusDrug: mycophenolate mofetilDrug: corticosteroidsDrug: daclizumab

2

ACTIVE COMPARATOR

Cyclosporine + Mycophenolate + Corticosteroids

Drug: cyclosporineDrug: mycophenolate mofetilDrug: corticosteroids

Interventions

sirolimusDRUG

15 mg loading dose, followed by 5 mg/day to achieve target trough levels of 10-15 ng/mL at months 1-6, then 8-12 ng/mL at months 7-12

1
cyclosporineDRUG

Initial dose of 10 mg/kg/day, then twice daily to achieve target trough levels of 300-400 ng/mL at weeks 0-4; 200-300 ng/mL at months 1-2; 150-250 ng/mL at months 2-3; 100-200 ng/mL at months 3-6; 75-150 ng/mL months 6-12

2
mycophenolate mofetilDRUG

1 g twice daily; may be reduced to 750 mg BID for adverse events, or to 500 mg BID for persisting adverse events

12
corticosteroidsDRUG

As per center practice. By day 8 prednisolone tapered to 20 mg/day; by day 30 to 15 mg/day; by day 60 to 10 mg/day; after 4 to 6 months to 5-7.5 mg/day

12
daclizumabDRUG

IV: 1 mg/kg to a maximum of 100 mg/dose. 5 doses at 2, 4, 6, and 8 weeks after transplantation

1

Eligibility Criteria

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

You may qualify if:

  • Kidney transplantation
  • Donor must be at least 60 years old.

You may not qualify if:

  • Current systemic infection
  • Unstable angina or treatment for serious arrhythmia.
  • Cancer within the previous 5 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Oslo, N-0027, Norway

Location

Unknown Facility

Gothenburg, SE-413 45, Sweden

Location

Unknown Facility

Uppsala, SE-751 85, Sweden

Location

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

SirolimusCyclosporineMycophenolic AcidAdrenal Cortex HormonesDaclizumab

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic ChemicalsCyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and ProteinsCaproatesAcids, AcyclicCarboxylic AcidsFatty AcidsLipidsHormonesHormones, Hormone Substitutes, and Hormone AntagonistsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
U. S. Contact Center
Organization
Wyeth
clintrialresults@wyeth.com

Study Officials

  • Medical Monitor, MD

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

  • Trial Manager

    For Norway, Sweden, MedInfoNord@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

September 12, 2005

First Posted

September 19, 2005

Study Start

November 1, 2004

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

NO(1)SE(2)