NCT07205692

Brief Summary

Who can participate? Any adults over the age of 18 who have received a kidney transplant at the research centre are eligible for recruitment within the first month after transplant What does the study involve? The study involves observing and gathering data to understand how the health of people who receive a kidney transplant changes over the first year. In particular the investigators are interested in the risk factors for heart disease and stroke, and how these change over the first year of transplant. The investigators are also interested in multiple health conditions, and how these impact patients after transplant. There are no interventions but there will be measurements of diagnoses, risk factors for heart disease and stroke, and assessments of physical fitness Blood pressure, BMI, routine blood tests as well as assessing muscle and fat changes, how fit patients are and what new health conditions they have. What are the possible benefits and risks of participating? There is no active treatment or intervention, so there are no risks of benefits compared to normal care. Where is the study run from? University Hospitals of Derby and Burton NHS trust, at the Royal Derby hospital Renal Department. When is the study starting and how long is it expected to run for? The study is expected to start 1/9/2025 and run for 2 years. Who is funding the study? The only costs of the study are funding for the staff member running the study, who is funded by the NIHR as an academic research fellow Who is the main contact? Dr Samuel Strain, Samuel.strain@nottingham.ac.uk

Trial Health

77
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
15mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress35%
Sep 2025Aug 2027

Study Start

First participant enrolled

September 5, 2025

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

September 10, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

October 3, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

October 3, 2025

Status Verified

September 1, 2025

Enrollment Period

1.9 years

First QC Date

September 10, 2025

Last Update Submit

September 25, 2025

Conditions

Keywords

multimorbiditykidney transplantrenal transplantcardiovascular risk

Outcome Measures

Primary Outcomes (1)

  • Multimorbidity

    The changes from baseline to year one of multimorbidity in the one year post kidney transplantation as measured by a disease count.

    One year after transplant

Secondary Outcomes (8)

  • Blood pressure

    One year

  • Lipid levels

    One year

  • Weight

    One year

  • HbA1c

    One year

  • Qualitative interview

    One year after transplant

  • +3 more secondary outcomes

Study Arms (1)

Incident kidney transplants

Incident kidney transplants returning from surgical centre for follow up

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Incident kidney transplant recipients returning to referring centre

You may qualify if:

  • Age ≥ 18 years old
  • Capable of giving informed consent
  • In receipt of a single organ renal transplant and being followed up by UHDB as the referring team.

You may not qualify if:

  • Graft failure before return to follow up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Derby Hospital

Derby, Derbyshire, DE22 3NE, United Kingdom

RECRUITING

Study Officials

  • Nicholas Selby

    University of Nottingham and UHDB

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Samuel Strain, BMBS

CONTACT

Nicholas Selby

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2025

First Posted

October 3, 2025

Study Start

September 5, 2025

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

October 3, 2025

Record last verified: 2025-09

Locations