Status:
COMPLETED
AZD1656 in Transplantation With Diabetes tO PromoTe Immune TOleraNce
Lead Sponsor:
Queen Mary University of London
Collaborating Sponsors:
AstraZeneca
Conditions:
Type 2 Diabetes
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 diab...
Detailed Description
Transplant recipients with pre-existing Type 2 diabetes frequently experience a deterioration in glycaemic control in the early post-transplant period, largely due to the significant immunosuppression...
Eligibility Criteria
Inclusion
- 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.
- Women of childbearing potential are defined as women following menarche until becoming post-menopausal, unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A post-menopausal state is defined as the absence of menses for 12 months without an alternative medical cause.
Exclusion
- 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
- Participation in an investigational drug trial in the 3 months prior to administration of the initial dose of study drug
- Highly effective contraception methods are defined as those that can achieve a failure rate of \<1% per year when used correctly and consistently. These include:
- Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation - either oral, transvaginal or transdermal
- Progestogen-only hormonal contraception associated with inhibition of ovulation - either oral, injectable or implantable
- Intrauterine device (IUD) or intrauterine hormone-releasing system (IUS)
- Bilateral tubal occlusion
- Vasectomised partner - provided that the partner is the sole sexual partner of the participant and that the vasectomised partner has received medical assessment of surgical success
Key Trial Info
Start Date :
December 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 11 2022
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT05216172
Start Date
December 13 2019
End Date
September 11 2022
Last Update
June 20 2024
Active Locations (1)
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1
Royal London Hospital Barts Health NHS Trust
London, United Kingdom, E1 1BB