AZD1656 in Transplantation With Diabetes tO PromoTe Immune TOleraNce

NCT05216172 | Completed Phase 2 DMC

• 1 other identifier: 252155
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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 diabetes

Conditions

Type 2 Diabetes; Diabetes Mellitus, Type 2; Renal Transplant; Kidney Transplant; Complications; End Stage Renal Disease

Keywords

Type 2 Diabetes Mellitus; Diabetes Mellitus; Renal transplantation; Regulatory T cells; AZD1656

Outcome Measures

Primary Outcomes (1)

• peripheral regulatory T cells

  Change in mean peripheral Treg cell number between baseline and 3 months measured using flow cytometry analysis (FACS) in AZD1656 and placebo arms

  14 weeks

Secondary Outcomes (9)

• regulatory T cells in renal transplant

  3 months

• delayed graft function

  1 week

• glycemic control: HbA1c

  3 months

• number of participants with increase or decrease in concurrent anti-diabetic medication

  3 months

• incidence of treatment emergent adverse events

  3 months

Other Outcomes (4)

• Comparison of patient and placebo group at 1 year post transplant: number of participants experiencing episodes of infection, rejection; comparison of renal function and diabetic control

  1 year

• T cell profile

  3 months

• regulatory T cells in renal transplant: biopsy for cause

  3 months

Study Arms (2)

AZD1656

EXPERIMENTAL

AZD1656 100mg BD for 3 months

Drug: AZD1656

placebo

PLACEBO COMPARATOR

placebo 100mg BD for 3 months

Drug: Placebo

Interventions

AZD1656 DRUG

active drug

AZD1656

Placebo DRUG

placebo

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen Mary University of London: lead
• AstraZeneca: collaborator

Study Sites (1)

Royal London Hospital Barts Health NHS Trust

London, E1 1BB, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Kidney Failure, Chronic; Diabetes Mellitus

Interventions

AZD1656

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kieran McCafferty, M.B., B.Chir

  Barts Health NHS Trust; Queen Mary University London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double blind placebo study: both the patient and the study team will be blinded to the treatment intervention. Pharmacy staff who dispense the study medication will not be blinded, nor will Sponsor Office staff responsible for reporting unblinded SUSAR reports to the MHRA.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single site, placebo controlled, double blind randomised clinical trial

Study Record Dates

• First Submitted: January 17, 2022
• First Posted: January 31, 2022
• Study Start: December 13, 2019
• Primary Completion: September 11, 2022
• Study Completion: September 11, 2022
• Last Updated: June 20, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose. The data may be used for individual participant data meta-analysis. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data may be found at \[email corresponding author??\]

Locations

GB (1)