AZD1656 in Transplantation With Diabetes tO PromoTe Immune TOleraNce (NCT05216172) | Clinical Trial Compass
CompletedPhase 2
AZD1656 in Transplantation With Diabetes tO PromoTe Immune TOleraNce
United Kingdom26 participantsStarted 2019-12-13
Plain-language summary
AZD1656 in Transplantation with Diabetes tO PromoTe Immune TOleraNce: a single site, placebo-controlled, double-blind randomised clinical trial of AZD1656 in renal transplant patients with Type 2 diabetes
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Females or males aged 18 years and above
✓. Having undergone renal transplantation at the Royal London Hospital within the previous 24 hours
✓. A pre-transplant diagnosis of Type 2 diabetes
✓. Provision of written, informed consent prior to any study specific procedures
✓. In women of childbearing potential\* documentation of a negative pregnancy test during admission for renal transplant.
Exclusion criteria
✕. Unable to consent
✕. Known allergy/intolerance to AZD1656
✕. Pregnant or breastfeeding women
✕. Planning on becoming pregnant/unwilling to use highly effective contraception\* during the 3 month treatment period and for 2 weeks afterwards (i) In the case of men with sexual partners who are women of childbearing potential: refusal to wear a condom and female partner planning on becoming pregnant/unwilling to use highly effective contraception\* during the 3 month treatment period and for 2 weeks afterwards
✕. Clinically significant history of abnormal physical and/or mental health as judged by the investigator other than conditions related to chronic kidney disease
✕. Current or planned use of strong inhibitors of CYP2C8