Efficacy and Safety of the Switch From Sirolimus to Everolimus in Stable Maintenance Renal Transplant Patients Receiving a Calcineurin Inhibitor Free Regimen
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|ClinicalTrials.gov Identifier: NCT00170820|
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : February 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Renal Transplantation||Drug: Everolimus||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||February 2005|
|Actual Primary Completion Date :||March 2006|
- Renal function at M6 (glomerular filtration and tubular function).
- Renal function (other tubular function parameters)
- Incidence of biopsy-proven acute rejections and CMV infections
- 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
- Mucous and cutaneous disorders
- Adverse events and serious adverse events, premature study treatment discontinuations.
- Monitoring of everolimus trough levels.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00170820