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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)
Lead sponsor
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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
Exclusion criteria
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 endpointsChange in Body Weight - Smart Scale
Time frame:26 weeks
Body weight, absolute change (kg)
change from baseline, improvement
Change in Body Fat - Smart Scale
Time frame:26 weeks
Total fat mass
percent change from baseline, improvement
Change in Muscle Mass - Smart Scale
Time frame:26 weeks
Lean mass
change from baseline, improvement
Change in Body Water Content - Smart Scale
Time frame:26 weeks
percent change from baseline, improvement
In-Clinic Height Measurement
Time frame:Baseline, 3 months, 6 months
descriptive
In-Clinic Weight Measurement
Time frame:Baseline, 3 months, 6 months
Body weight, absolute change (kg)
change from baseline, improvement
In-Clinic Body Mass Index Measurement
Time frame:Baseline, 3 months, 6 months
BMI, change
change from baseline, improvement
Glycemic / diabetes
3 endpointsPercentage of Change in HbA1c
Time frame:26 weeks
HbA1c, % change
percent change from baseline, improvement
LOINC 4548-4
Change in 2-week glycemic variability
Time frame:26 weeks
percent change from baseline, improvement
Change in Time-in-Range
Time frame:26 weeks
CGM time-in-range
percent change from baseline, improvement
Renal / kidney
1 endpointIncidence of Acute Kidney Injury
Time frame:12 months
time to event, event
Safety / tolerability / PK
3 endpointsAdherence to GLP-1RA Therapy
Time frame:12 months
threshold achievement, descriptive
Incidence of Hypoglycemia
Time frame:12 months
event count, event
Incidence of Gastrointestinal Side Effects
Time frame:12 months
event count, event
Other clinical outcomes
3 endpointsAdherence to Scheduled Coaching Visits
Time frame:12 months
threshold achievement, descriptive
Change in Dalhousie Clinical Frailty Scale Classification
Time frame:26 weeks
change from baseline, improvement
Change in SARC-F Score of Sarcopenia
Time frame:26 weeks
change from baseline, improvement
Other (unclassified)
3 endpointsFeasibility of Recruitment
Time frame:12 months
threshold achievement, descriptive
Recruitment of ≥20 Participants in First 12 Weeks
Time frame:First 12 weeks
threshold achievement, descriptive
Recruitment Per Site Within 12 Weeks
Time frame:First 12 weeks
threshold achievement, descriptive
Provenance
Sources
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.