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A comparison of Sirolimus versus Tacrolimus as a delayed treatment of recipients of non heart beating donor kidneys after anti-IL2 monoclonal antibody - Sirolimus vs Tacrolimus for NHBD Kidney Recipients after IL-2 mAb

A comparison of Sirolimus versus Tacrolimus as a delayed treatment of recipients of non heart beating donor kidneys after anti-IL2 monoclonal antibody - Sirolimus vs Tacrolimus for NHBD Kidney Recipients after IL-2 mAb

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-001265-41-GB
Enrollment
60
Registered
2006-04-18
Start date
2006-06-16
Completion date
Unknown
Last updated
2019-06-30

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

Conditions

Kidney transplantation from non heart beating donors for end-stage renal disease

Interventions

Trade Name: Sirolimus (Rapamune) Product Name: Sirolimus Pharmaceutical Form: Tablet

Sponsors

Newcastle upon Tyne Hospitals NHS Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Recipients of kidneys from non heart beating donors Age 18-75 Written informed consent obtained from the patient after receiving a comprehensive explanation Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Pregnant women Recipients of multiple transplants (e.g. Both kidneys from one donor transplanted into one recipient or a simultaneous kidney and liver or kidney and pancreas transplant)

Design outcomes

Primary

MeasureTime frame
Main Objective: To compare the effects of sirolimus and tacrolimus on kidney function following non heart beating donor kidney transplantation into adult recipients.;Secondary Objective: To determine if the drugs have different effects on patient survival, survival of the transplanted kidney, acute rejection, chronic rejection and complications following surgery.;Primary end point(s): The primary end points are creatinine and calculated GFR (glomerular filtration rate) at monthly intervals from the date of transplant to 12 months.

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026