NCT00284947

Brief Summary

The long-term use of calcineurin inhibitors (CNI) in patients who have received a kidney transplantation is associated with renal dysfunction and hypertension. The study will evaluate the safety and efficacy of replacing the calcineurin inhibitors by using basiliximab at monthly doses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2006

Typical duration for phase_4

Geographic Reach
1 country

1 active site

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

January 1, 2006

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

January 30, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 1, 2006

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

March 29, 2017

Status Verified

March 1, 2017

Enrollment Period

2.9 years

First QC Date

January 30, 2006

Last Update Submit

March 27, 2017

Conditions

Kidney TransplantationAdverse Effects

Keywords

Side effectscalcineurin inhibitorsmaintenancebasiliximabKidney maintenance transplant

Outcome Measures

Primary Outcomes (1)

  • to describe the pharmacokinetics of basiliximab over the 6-month study course and to determine whether serum concentrations remain above CD25 receptor saturation levels

    6 months

Secondary Outcomes (5)

  • to evaluate the risk of sensitization against the chimeric antibody over 6 months

    6 months

  • to assess the changes in renal parameters after CNI discontinuation

    Month 1-6 post trasnplant

  • to assess the quantifiable changes in vital signs and lab abnormalities possibly related to CNIs

    6 months

  • to assess semi-quantitatively changes of clinical symptoms possibly related to CNIs

    6 month

  • to determine the percentage of CD25 positive T cells (CD3) during therapy with Simulect

    24 weeks

Study Arms (1)

Maintenance immunosuppression

EXPERIMENTAL

40mg Simulect i.v, once every 28 days for 24 weeks (treatment periods) * 1g MMF or 720mg EC-MPS p.o twice daily * Oral corticosteroids

Drug: basiliximabDrug: MMF/EC-MPSDrug: Corticosteroids

Interventions

basiliximabDRUG

40 mg once every 28 days intravenously for 24 weeks

Also known as: Simulect
Maintenance immunosuppression
MMF/EC-MPSDRUG

1g MMF or 720mg EC-MPS p.o twice daily

Also known as: MPA, Myfortic, Cellcept
Maintenance immunosuppression
CorticosteroidsDRUG

Oral corticosteroids, equivalent to prednisone p.o, ≥ 5mg daily or ≥ 10mg on alternate days

Also known as: Prednisone, Methyl-prednisolone
Maintenance immunosuppression

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a first kidney transplant from a living or deceased donor at least 12 months after transplantation.
  • Patients receiving CNI, mycophenolic acid (MPA) and oral corticosteroids.
  • Patients who are able to tolerate full dose MPA.
  • Patients with glomerular filtration rate (GFR) \> 30 mL/min.
  • Patients without an acute rejection episode during the preceding 6 months.
  • Patients with signs or symptoms of CNI intolerance (renal dysfunction, poor blood pressure control, diabetes, poor lipid control, hyperuricemia and gout, significant hypophosphatemia or hypomagnesemia, gingival hyperplasia, hypertrichosis, etc.) in whom CNI interruption is justified.

You may not qualify if:

  • Patients with preformed positive skin test against basiliximab
  • Patients with preformed panel reactive antibody (PRA) \> 10%.
  • Signs of active immune process on graft biopsy.
  • Patients with multi-organ or second kidney transplant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis

Basel, Switzerland

Location

MeSH Terms

Interventions

BasiliximabMycophenolic AcidAdrenal Cortex HormonesPrednisone

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsCaproatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty AcidsLipidsHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Novartis

    Novartis

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2006

First Posted

February 1, 2006

Study Start

January 1, 2006

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

March 29, 2017

Record last verified: 2017-03

Locations

CH(1)