NCT04973982

Brief Summary

Our hypothesis is that switching from the current standard of care twice daily Adoport (Tacrolimus) to once daily Envarsus (tacrolimus) in patients who have impaired glucose tolerance post-transplant will lead to an improvement in their glucose tolerance, and may reduce the subsequent incidence of PTDM.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 22, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

January 31, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

April 1, 2022

Status Verified

July 1, 2021

Enrollment Period

6 months

First QC Date

July 12, 2021

Last Update Submit

March 21, 2022

Conditions

Renal Transplant Failure

Outcome Measures

Primary Outcomes (1)

  • The proportion of patients who normalise their IGT (defined as a blood glucose level between <7.8mmol/l) after a two-hour oral glucose tolerance test at three months after randomisation.

    The proportion of patients who normalise their IGT (defined as a blood glucose level between \<7.8mmol/l) after a two-hour oral glucose tolerance test at three months after randomisation.

    3 months

Secondary Outcomes (7)

  • Change in HOMA-IR test between 0 and 3 months post-randomisation This parameter will be compared on the ITT dataset using unpaired T test. P values of < 0.05 will be considered statistically significant

    3 month

  • Proportion of patients developing PTDM during the study

    3 month

  • Change in HbA1c between baseline and 3 months This parameter will be compared on the ITT dataset using unpaired T test. P values of < 0.05 will be considered statistically significant.

    3 month

  • Change in eGFR between baseline and 3 months This parameter will be compared on the ITT dataset using unpaired T test. P values of < 0.05 will be considered statistically significant.

    3 month

  • Change in fasting blood sugar between randomisation and month 3 This parameter will be compared on the ITT dataset using unpaired T test. P values of < 0.05 will be considered statistically significant.

    3 month

  • +2 more secondary outcomes

Study Arms (2)

ENVARSUS

ACTIVE COMPARATOR

ENVARSUS used as per licence

Drug: Envarsus

ADOPORT

ACTIVE COMPARATOR

ADOPTION used as per licence

Drug: Adoport

Interventions

EnvarsusDRUG

3 month treatment, given once daily, oral tablet. Dose titrated according to levels target 6-10ng/ml

ENVARSUS
AdoportDRUG

3 month treatment, given twice daily, oral tablet. Dose titrated according to levels target 6-10ng/ml

Also known as: Tacrolimus
ADOPORT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Females or males aged 18 years and above
  • Having undergone renal transplantation within the previous 2 years
  • Current treatment with tacrolimus
  • Evidence of impaired glucose tolerance (defined as a blood glucose level between 7.8-11.1 mmol/L after a two hour oral glucose tolerance test)
  • Provision of written, informed consent prior to any study specific procedures

You may not qualify if:

  • Unable to consent
  • Planning on becoming pregnant/unwilling to use highly effective contraception during the 3-month treatment period or breastfeeding.
  • Clinically significant history of abnormal physical and/or mental health as judged by the investigator other than conditions related to chronic kidney disease
  • History of Type 1 or Type 2 diabetes mellitus; or on treatment with anti-diabetic medications
  • Prior therapy with Envarsus
  • Exposure to an investigational drug withing the preceding 3 months, or 5 half-lives whichever is greater.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barts Health NHS Trust

London, E1 1BB, United Kingdom

Location

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective, open label, single centre, randomised parallel-group controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2021

First Posted

July 22, 2021

Study Start

January 31, 2022

Primary Completion

August 1, 2022

Study Completion

October 1, 2022

Last Updated

April 1, 2022

Record last verified: 2021-07

Locations

GB(1)