A study to see whether giving the drug heme-arginate to recipients before kidney transplant can increase the level of a protective protein and protect their transplanted kidney.
Phase 1
- Conditions
- Ischaemia-reperfusion injury in renal transplantationMedDRA version: 20.1 Level: LLT Classification code 10014646 Term: End stage renal disease (ESRD) System Organ Class: 100000004857MedDRA version: 20.0 Level: LLT Classification code 10023438 Term: Kidney transplant System Organ Class: 100000004865Therapeutic area: Body processes [G] - Cell Physiological Phenomena [G04]
- Registration Number
- EUCTR2011-004311-23-GB
- Lead Sponsor
- niversity of Edinburgh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
All patients receiving a single kidney deceased donor transplant.
All patients receiving standard immunosuppression.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 35
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
Exclusion Criteria
Patients unable to receive the standard immunosuppressive regimen
Patients unable to give informed consent
Patients with known hypersensitivity reactions to HA
Patients receiving more than one organ
Patients receiving their 3rd or subsequent kidney transplant
Patients who are fully anticoagulated pre-operatively
Patients on combined anti-platelet agents
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method