← Trials/Trial dossier/NCT06396416

RecruitingPhase 4

Obesity Management for Kidney TRANSPLANTation: OK-TRANSPLANT 2

Obesity Management for Kidney TRANSPLANTation: a Vanguard Study for an Innovative Randomized Controlled Trial, Embedded in Routine Care (OK-TRANSPLANT 2)

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

1

Enrollment

60

estimated

Study population

Chronic kidney disease, Obesity / overweight

Key I/E criterion

Primary endpoint

Feasibility of Recruitment

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06396416
Org study IDOK-TRANSPLANT 2

Timeline

Milestones

Study first posted2024-05-02actual
Study start2024-09-26actual
Last update posted2026-02-20actual
Primary completion2026-02estimated (month precision)
Study completion2026-02estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Chronic kidney diseaseObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

Adults aged 18 years or older
BMI \> 35 kg/m^2
\>10% risk of ESKD requiring renal replacement therapy over 2 years or receiving dialysis

Exclusion criteria

Known contraindication to a GLP-1RA
Type 1 diabetes
No access to semaglutide via drug coverage
Absolute contraindication to kidney transplant
Pregnant, breastfeeding or planning to become pregnant
Currently in a GLP-1RA or GLP-1RA/GIP study or planning to be in one

Endpoints (20)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition
7
Glycemic / diabetes
3
Safety / tolerability / PK
3
Other clinical outcomes
3
Other (unclassified)
3
Renal / kidney
1

Weight & body composition

7 endpoints
Secondary/protocol endpoint

Change in Body Weight - Smart Scale

Time frame:26 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in Body Fat - Smart Scale

Time frame:26 weeks

Total fat mass

percent change from baseline, improvement

Secondary/protocol endpoint

Change in Muscle Mass - Smart Scale

Time frame:26 weeks

Lean mass

change from baseline, improvement

Secondary/protocol endpoint

Change in Body Water Content - Smart Scale

Time frame:26 weeks

percent change from baseline, improvement

Secondary/protocol endpoint

In-Clinic Height Measurement

Time frame:Baseline, 3 months, 6 months

descriptive

Secondary/protocol endpoint

In-Clinic Weight Measurement

Time frame:Baseline, 3 months, 6 months

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

In-Clinic Body Mass Index Measurement

Time frame:Baseline, 3 months, 6 months

BMI, change

change from baseline, improvement

Glycemic / diabetes

3 endpoints
Other/protocol endpoint

Percentage of Change in HbA1c

Time frame:26 weeks

HbA1c, % change

percent change from baseline, improvement

LOINC 4548-4

Other/protocol endpoint/low confidence

Change in 2-week glycemic variability

Time frame:26 weeks

percent change from baseline, improvement

Other/protocol endpoint

Change in Time-in-Range

Time frame:26 weeks

CGM time-in-range

percent change from baseline, improvement

Renal / kidney

1 endpoint
Secondary/protocol endpoint

Incidence of Acute Kidney Injury

Time frame:12 months

time to event, event

Safety / tolerability / PK

3 endpoints
Secondary/protocol endpoint/low confidence

Adherence to GLP-1RA Therapy

Time frame:12 months

threshold achievement, descriptive

Secondary/protocol endpoint

Incidence of Hypoglycemia

Time frame:12 months

event count, event

Secondary/protocol endpoint

Incidence of Gastrointestinal Side Effects

Time frame:12 months

event count, event

Other clinical outcomes

3 endpoints
Secondary/protocol endpoint/low confidence

Adherence to Scheduled Coaching Visits

Time frame:12 months

threshold achievement, descriptive

Secondary/protocol endpoint

Change in Dalhousie Clinical Frailty Scale Classification

Time frame:26 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in SARC-F Score of Sarcopenia

Time frame:26 weeks

change from baseline, improvement

Other (unclassified)

3 endpoints
Primary/protocol endpoint

Feasibility of Recruitment

Time frame:12 months

threshold achievement, descriptive

Secondary/protocol endpoint

Recruitment of ≥20 Participants in First 12 Weeks

Time frame:First 12 weeks

threshold achievement, descriptive

Secondary/protocol endpoint

Recruitment Per Site Within 12 Weeks

Time frame:First 12 weeks

threshold achievement, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.