The ADOPTION Study: AZD1656 in Transplantation with Diabetes tO PromoTe Immune TOleraNce

Phase 1

• Conditions: renal transplant AND type 2 diabetes; MedDRA version: 20.0Level: LLTClassification code 10023438Term: Kidney transplantSystem Organ Class: 100000004865; MedDRA version: 20.0Level: PTClassification code 10012601Term: Diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2019-001587-30-GB
• Lead Sponsor: Queen Mary University London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-03
• Last Update Posted: 25 May 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

a)Females or males aged 18 years and above
b)Having undergone renal transplantation at the Royal London Hospital within the previous 24 hours
c)A pre-transplant diagnosis of Type 2 diabetes
d)Provision of written, informed consent prior to any study specific procedures
e)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.
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 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

a)Unable to consent
b)Known allergy/intolerance to AZD1656
c)Pregnant or breastfeeding women
d)Planning on becoming pregnant/unwilling to use highly effective contraception* during the 3 month treatment period and for 2 weeks afterwards
a.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
e)Clinically significant history of abnormal physical and/or mental health as judged by the investigator other than conditions related to chronic kidney disease
f)Current or planned use of strong inhibitors of CYP2C8
g)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
•Sexual abstinence – refrain from heterosexual intercourse for the duration of period defined to be at risk

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified