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OpenTrials
Completed

NCT Number: NCT00284947

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

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.

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Key information

Conditions

Kidney Transplantation Adverse Effects

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis

Basel, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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/exclusion criteria may apply.

Treatment and study plan

Basiliximab

Drug

40 mg once every 28 days intravenously for 24 weeks

Other names: Simulect

MMF/EC-MPS

Drug

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

Other names: MPA, Myfortic, Cellcept

Corticosteroids

Drug

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

Other names: Prednisone, Methyl-prednisolone

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

    Time frame: 6 months

Secondary outcomes

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

    Time frame: 6 months

  2. to assess the changes in renal parameters after CNI discontinuation

    Time frame: Month 1-6 post trasnplant

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

    Time frame: 6 months

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

    Time frame: 6 month

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

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Feb 1, 2006
Registry last updated
Mar 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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