A clinical trial where a change in medication can reduce the incidence of diabetes after renal transplantation.
- Conditions
- Therapeutic area: Body processes [G] - Immune system processes [G12]Prophylaxis of rejection in kidney allograft recipients (by immunosuppression)MedDRA version: 14.1Level: LLTClassification code 10050436Term: Prophylaxis against renal transplant rejectionSystem Organ Class: 10042613 - Surgical and medical procedures
- Registration Number
- EUCTR2012-000451-13-SE
- Lead Sponsor
- Transplant Institute, Sahlgrenska University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 223
1. Patients receiving a first or second single kidney transplant from a deceased or a living donor.
2. Female or male aged above 18 years
3. Patients considered for a standard immunosuppressive protocol.
4. Patients capable of giving written informed consent for participation in the study for 24 months
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 160
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40
1. Patients with known diabetes mellitus or plasma glucose >11.1 mmol/l at admission
2. Recipients of multiorgan transplants, and or previously transplanted with any other organ than kidney
3. Patients with CDC-PRA > 25 % in most recent test or for any other reason considered to be of a high risk for rejection which requires an enhanced immunosuppression.
4. Patients receiving a renal transplant from a HLA-identical sibling
5. Patients with hypersensitivity to, or other reasons to not be able to take the immunosuppressive drugs used in the study
6. Patients who are recipients of ABO-incompatible transplants
7. Patients who are unlikely to comply with the study requirements
8. Patients, and/or those receiving organs from donors, who are positive for HIV, Hepatitis B surface antigen or Hepatitis C virus.
9. Females of childbearing potential, who are, or are planning to be, pregnant, and/or are unwilling to use effective means of contraception.
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