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NCT00170820 Clinical Trial

Efficacy and Safety of the Switch From Sirolimus to Everolimus in Stable Maintenance Renal Transplant Patients Receiving a Calcineurin Inhibitor Free Regimen

Renal Transplantation Clinical Trial

Official title:
A Single Arm, Prospective, Open-label, Pilot Study to Assess Effects of the Switch From Sirolimus to Everolimus in Stable Maintenance Renal Transplant Patients Receiving a Calcineurin Inhibitor Free Regimen

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00170820
Other study ID # CRAD001AFR04
Secondary ID
Status Completed
Phase Phase 4
First received September 9, 2005
Last updated February 23, 2017
Start date February 2005

Study information
Verified date February 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess if a combination of everolimus, steroids, and mycophenolate mofetil is associated with a better renal function than sirolimus.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date
Est. primary completion date March 2006
Accepts healthy volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- First or second renal transplantation (1 to 10 years post-transplant)

- Treatment with sirolimus + mycophenolate mofetil + steroids + ACE inhibitor or angiotensin II receptor antagonist + statin

Exclusion Criteria

- Treatment with a CNI or azathioprine

- Vascular rejection or biopsy-proven acute rejection within 3 months prior to screening

- Severe dyslipidemia Other protocol-defined inclusion / exclusion criteria may apply

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Everolimus

Locations
Country Name City State
Switzerland Novartis Basel

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Kamar N, Jaafar A, Esposito L, Ribes D, Durand D, Di-Giambattista F, Tack I, Rostaing L. Conversion from sirolimus to everolimus in maintenance renal transplant recipients within a calcineurin inhibitor-free regimen: results of a 6-month pilot study. Clin — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Renal function at M6 (glomerular filtration and tubular function).
Secondary Renal function (other tubular function parameters)
Secondary Incidence of biopsy-proven acute rejections and CMV infections
Secondary Laboratory parameters: hemoglobin, WBC, T-cell sub-populations, platelets, transaminases, total cholesterol, HDL and LDL cholesterol, apolipoproteins A1 and B, triglycerides, fasting glucose, HbA1c, LH, FSH, testosterone and TSH
Secondary Mucous and cutaneous disorders
Secondary Adverse events and serious adverse events, premature study treatment discontinuations.
Secondary Monitoring of everolimus trough levels.
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