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Everolimus in a Cyclosporine Microemulsion-free Regimen Compared to a Low-dose Cyclosporine Microemulsion Regimen, in de Novo Kidney Transplant Patients

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Organ Transplantation, Renal Transplantation

Intervention: Everolimus (Certican) (Drug); Cyclosporine (Neoral) (Drug); Steroid (Drug); Basiliximab (Simulect) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis, Study Director, Affiliation: Novartis

Summary

The purpose of this study is to evaluate the safety and efficacy of everolimus in combination with basiliximab, and steroids with and without cyclosporine microemulsion in de novo kidney transplant recipients.

Clinical Details

Official title: A 12 Month, Multicenter, Randomized, Parallel, Open-label Study, to Evaluate Renal Function and Efficacy of Everolimus With Basiliximab and Cyclosporine Microemulsion Discontinuation at 3 Month Post-transplant Versus Minimization, in de Novo Kidney Transplant Recipients

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Renal Function Measured by Calculated Glomerular Filtration Rate (GFR Calculated According to the Nankivell Formula)

Secondary outcome:

Number of Participants With Biopsy-proven Acute Rejection (BPAR) Episodes, Graft Loss, Death or Loss to Follow-up

Serum Creatinine at Month 6 and 12

Calculated Creatinine Clearance at 6 Month and 12 Month

Safety Based on Adverse Event (AE) Reporting

Detailed description: This is a combined analysis using 81 patients randomized and treated in CRAD001A2419 (NCT00154284) with 33 randomized and treated in CRAD001A2423 (NCT00170807). This approach is reflected in the protocol amendments for each study, and the one clinical study report for both.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Recipients of a first renal transplant from a primary cadaveric or non-HLA identical

living related donor.

- Renal cold ischemic time < 36 hours.

- Age of donor < 65 years.

Exclusion Criteria:

- Patients who have received an investigational drug within 4 weeks of baseline period.

- Patients who are recipients of multiple organ transplants, including any organ other

than kidney.

- Recipients of non-heart beating donor organs.

Other protocol-defined exclusion criteria may apply.

Locations and Contacts

Additional Information

Starting date: July 2005
Last updated: March 28, 2011

Page last updated: August 23, 2015

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