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

Influence on hemodynamics of conversion from Calcineurin Inhibitor to Sirolimus in Renal and Liver Transplant patients older than 18 year

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000835044

Enrollment

Registered

2010-10-06

Start date

2004-09-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Switch calcineurin inhibitor (CNI) to Sirolimus treatment; Sirolimus dose:Loading dose 10-15 mg/d (at clinicians discretion); d 2-6:3-5 mg/d (at clinicians discretion), after d 7,sirolimus dosage was adjusted to target through level of 6–16 ng/mL study duration: 1 year. administration: oral capsule

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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

Outcome results