Safety and Efficacy of Basiliximab in Calcineurin Inhibitor Intolerant Long-term Kidney Transplant Recipients Treated With Mycophenolic Acid and Steroids

REPLACE: Safety and Efficacy of Basiliximab in Calcineurin Inhibitor Intolerant Long-term Kidney Transplant Recipients Treated With Mycophenolic Acid and Steroids

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00284947

Enrollment

Registered

2006-02-01

Start date

2006-01-31

Completion date

2008-12-31

Last updated

2017-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adverse Effects, Kidney Transplantation

Keywords

Side effects, calcineurin inhibitors, maintenance, basiliximab, Kidney maintenance transplant

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.

Interventions

DRUGbasiliximab

40 mg once every 28 days intravenously for 24 weeks

DRUGMMF/EC-MPS

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

DRUGCorticosteroids

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* 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 Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026