PIVOT

Not yet recruitingPhase 4

Patient-centred Intervention With Virtual Support for Obesity and Kidney Transplant Access

Lead sponsor

Kristin Clemens

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Estimated enrollment

880

Study population

Chronic kidney disease, Obesity / overweight

Eligibility highlights

•BMI ≥35•eGFR ≤15

Primary endpoint

•Body Weight

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07858331

Org study IDPIVOT

Timeline

Milestones

Study first posted2026-10-05actual

Last update posted2026-10-05actual

Study start2027-01-01estimated

Primary completion2029-01-01estimated

Study completion2029-01-01estimated

Assets

Investigational agents

Semaglutide

Who this study enrolls

Chronic kidney diseaseObesity / overweight

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•18 years or older

•BMI >35 kg/m2

•eGFR <15ml/min/1.73m2 at baseline OR 2-year KFRE2 of 10% or greater

Exclusion criteria

•Known contraindication to a GLP-1RA (pancreatitis, personal or family history of medullary thyroid cancer, hypersensitivity, pregnancy, breastfeeding)

•Type 1 diabetes

Endpoints (45)

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

Other (unclassified)

Weight & body composition

Renal / kidney

Cardiovascular outcomes

Glycemic / diabetes

Patient-reported / QoL

Safety / tolerability / PK

Other clinical outcomes

Cardiovascular outcomes

2 endpoints

Other/protocol endpoint

Hospitalization for Hyperglycemia

Time frame:Baseline to 24 Months

descriptive

Other/protocol endpoint

Hospitalization for hypoglycemia

Time frame:Baseline to 24 Months

descriptive

Weight & body composition

7 endpoints

Primary/protocol endpoint

Change in Body Weight

Time frame:Baseline to 26 weeks +/- 14 days

change from baseline, improvement

Secondary/protocol endpoint

Weight Loss ≥5%

Time frame:Baseline to 26 weeks +/- 14 days

threshold achievement, improvement

Secondary/protocol endpoint

Weight Loss ≥10%

Time frame:Baseline to 26 weeks +/- 14 days

threshold achievement, improvement

Secondary/protocol endpoint

Weight Loss ≥15%

Time frame:26 weeks +/- 14 days

threshold achievement, improvement

Secondary/protocol endpoint

Weight Loss ≥20%

Time frame:Baseline to 26 weeks +/- 14 days

threshold achievement, improvement

Secondary/protocol endpoint

Body Mass Index (BMI)

Time frame:Baseline to 26 weeks +/- 14 days

descriptive

Secondary/protocol endpoint

Body Mass Index <35 kg/m²

Time frame:Week 26 +/- 14 days

descriptive

Glycemic / diabetes

2 endpoints

Secondary/protocol endpoint

Diabetic Retinopathy Interventions

Time frame:Baseline to 26 weeks +/- 14 days

descriptive

Other/protocol endpoint

Change in HbA1c

Time frame:Baseline to 24 Months

change from baseline, improvement

Renal / kidney

4 endpoints

Secondary/protocol endpoint

Quality of Life - Kidney Disease Quality of Life 36-Item Short Form

Time frame:Baseline to 26 weeks +/- 14 days

descriptive

Secondary/protocol endpoint

Change in Functional Status - Kidney Disease Quality of Life 36-Item Short form (KDQOL-36)

Time frame:Baseline to 26 weeks +/- 14 days

change from baseline, improvement

Secondary/protocol endpoint

Acute Kidney Injury (AKI)

Time frame:Baseline to 26 weeks +/- 14 days

descriptive

Other/protocol endpoint

Kidney Transplantation

Time frame:Baseline to 24 months

descriptive

Patient-reported / QoL

2 endpoints

Secondary/protocol endpoint

Health-Related Quality of Life - European Quality of Life 5 Dimensions, 5 Level (EQ-5D-5L) Questionnaire

Time frame:Baseline to 26 weeks +/- 14 days

descriptive

Secondary/protocol endpoint

Change in Functional Status - European Quality of Life five-dimensional, five-level generic measure (EQ-5D-5L) scores across treatment arms.

Time frame:Baseline to 26 weeks +/- 14 days

change from baseline, improvement

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Hypoglycemia

Time frame:Baseline to week 26 +/- 14 days

descriptive

Secondary/protocol endpoint

Gastrointestinal Symptoms

Time frame:Baseline to 26 weeks +/- 14 days

descriptive

Other clinical outcomes

1 endpoint

Secondary/protocol endpoint

Coaching Visit Adherence

Time frame:Baseline to 26 weeks +/- 14 days

descriptive

Other (unclassified)

25 endpoints

Secondary/protocol endpoint/low confidence

Body Surface Area (BSA)

Time frame:Baseline to 26 weeks +/- 14 days

descriptive

Secondary/protocol endpoint/low confidence

Dalhousie Clinical Frailty Scale Rating

Time frame:Baseline to 26 weeks +/- 14 days

descriptive

Secondary/protocol endpoint/low confidence

SARC-F Score

Time frame:Baseline to 26 weeks +/- 14 days

descriptive

Secondary/protocol endpoint/low confidence

FRAIL Scale

Time frame:Baseline to 26 weeks +/- 14 days

descriptive

Secondary/protocol endpoint/low confidence

Acute Biliary Disease

Time frame:Baseline to 26 weeks +/- 14 days

descriptive

Secondary/protocol endpoint/low confidence

Acute Pancreatitis

Time frame:Baseline to 26 weeks +/- 14 days

descriptive

Secondary/protocol endpoint/low confidence

Injection-site reactions

Time frame:Baseline to 26 weeks +/- 14 days

descriptive

Secondary/protocol endpoint/low confidence

Malignant Neoplasms

Time frame:Baseline to 26 weeks +/- 14 days

descriptive

Secondary/protocol endpoint/low confidence

Semaglutide Discontinuation

Time frame:Baseline to 26 weeks +/- 14 days

descriptive

Secondary/protocol endpoint/low confidence

Achievement of semaglutide dose ≥1.0 mg/week

Time frame:Week 26 +/- 14 days

threshold achievement, improvement

Secondary/protocol endpoint/low confidence

Achievement of Semaglutide Dose ≥2.0 mg/week

Time frame:26 weeks +/- 14 days

threshold achievement, improvement

Secondary/protocol endpoint/low confidence

Semaglutide Initiation in Usual Care

Time frame:Baseline to 26 weeks +/- 14 days

descriptive

Secondary/protocol endpoint/low confidence

Use of Semaglutide in Usual Care Participants

Time frame:Baseline to 26 weeks +/- 14 days

descriptive

Secondary/protocol endpoint/low confidence

Semaglutide Dose ≥1.0 mg/Week in Usual care Arm

Time frame:26 weeks +/- 14 days

threshold achievement, improvement

Secondary/protocol endpoint/low confidence

Semaglutide Dose ≥2.0 mg/Week in Usual Care Arm

Time frame:26 Weeks +/- 14 days

threshold achievement, improvement

Secondary/protocol endpoint/low confidence

Body Fat Percentage Measured with Smart Scale

Time frame:Baseline to 26 weeks +/- 14 days

descriptive

Secondary/protocol endpoint/low confidence

Muscle Mass Measured with Smart Scale

Time frame:Baseline to 26 weeks +/- 14 days

descriptive

Secondary/protocol endpoint/low confidence

Intervention Costs

Time frame:Baseline to 26 weeks

descriptive

Secondary/protocol endpoint/low confidence

Out-of-pocket costs

Time frame:Baseline to 26 weeks

descriptive

Secondary/protocol endpoint/low confidence

Lost Productivity Costs

Time frame:Baseline to 26 weeks

descriptive

Secondary/protocol endpoint/low confidence

Health care utilization costs

Time frame:Baseline to 26 weeks

descriptive

Other/protocol endpoint/low confidence

Initiation of Dialysis

Time frame:Baseline to 24 Months

descriptive

Other/protocol endpoint/low confidence

Cardiovascular Composite

Time frame:Baseline to 24 Months

descriptive

Other/protocol endpoint/low confidence

Healthcare utilization

Time frame:24 months

descriptive

Other/protocol endpoint/low confidence

Health care costs

Time frame:24 months

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 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 November 5, 2026 snapshot.