Influence on hemodynamics of conversion from Calcineurin Inhibitor to Sirolimus in Renal and Liver Transplant patients

Phase 4

Completed

• Conditions: renal allograft recipients or liver allograft recipients; Renal and Urogenital - Kidney disease; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12610000835044
• Lead Sponsor: niversity Hospital Bern

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-10-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

renal of liver allograft recipient
-creatinine clearance > 30ml/min

Exclusion Criteria

- signs of acute rejection

- evidence of active systemic or localised major infection

-known or suspected malignancy ( exception skin malignancies)

- -renal arterial stenosis > 50 % reduction in luminal diameter

-hydronephros

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
-renal resistance index assessed by dopplersonography[one year following randomisation]

Secondary Outcome Measures

Name	Time	Method
-aortic stiffness measured by pulse plethysmography<br><br><br>-[one year following randomisation];-renal function test: analysis of plasma creatinine levels[one year following randomisation];patient and graft survival<br>tools: data linkage to medical records[one year following randomisation];-incidence of treated acute rejections<br>tools: data linkage to medical records[one year following randomisation];-arterial hypertension<br>test: automatic sphygmomanometer[one year following randomisation];-incidence of hyperlipidemia/ diabetes mellitus<br>-severity of hyperlipidemia/ diabete mellitus<br>test: blood analysis of cholesterol and glycosilated hemiglobin[one year following randomisation]