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

28. september 2026 oppdatert av: Kristin Clemens

Obesity has a serious impact on people's health and quality of life. For those with advanced kidney disease (i.e. approaching the need for dialysis), obesity is especially problematic - obesity can not only lead to worsening kidney function and kidney failure, but it can also prevent patients from receiving a lifesaving kidney transplantation due to concerns about operation risks. Unfortunately, there is an urgent need but no rigorously proven treatments to help people with advanced kidney disease lose weight effectively and safely.

The investigative team is a large team of doctors, nurses, dieticians, exercise specialists, social scientists, and patients with a lived experience, have spent three years advancing research to help people with advanced kidney disease achieve a healthier body weight. They have created a special weight loss program that combines individualized coaching on diet and save activity with a medication proven to help people with healthier kidneys lose weight (i.e. Ozempic). This research program is called PIVOT: Patient-centred Intervention with Virtual support for Obesity and kidney Transplant access.

The investigators have started to test PIVOT in a small pilot study and early results show that there is potential to study the program on a much larger scale (i.e. across Canada). With funding from CIHR, the investigators aim to reach more Canadians with advanced kidney disease (including people of lower income, women, and people of different races) with an aim of helping them lose weight safely, feel better, obtain a kidney transplant, and staying healthier over the longer term.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

880

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Virtual Weight Management Program

A maximum tolerated dose of semaglutide will be administered once weekly subcutaneously, up to a dose of 2.0 mg. Participants will also receive nutritional and movement advice, as well as virtual coaching once every 4 weeks for 6 months.

Maximum tolerated dose of semaglutide subcutaneously once weekly. Maximum dose of 2.0 mg.

Andre navn:
  • Ozempisk
  • Wegovy
  • Generic Semaglutide
  • Apo-Semaglutide
  • Semaglutide Injection

Virtual meeting with intervention coach once every 4 weeks for 6 months, where the coach will discuss the goals and progress with participant, nutritional advice, exercise advice, and motivational support.

Andre navn:
  • Vekt styring
  • Coaching
Ingen inngripen: Usual Care

Usual care participants will continue to receive the typical standard of kidney and diabetes care. They will not receive any study medication or coaching.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Body Weight
Tidsramme: Baseline to 26 weeks +/- 14 days

Continuous measure of weight in kilograms assessed on calibrated clinic scales (dry weight for those receiving dialysis given fluid shifts)

Baseline to 26 weeks +/- 14 days

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Quality of Life - Kidney Disease Quality of Life 36-Item Short Form
Tidsramme: Baseline to 26 weeks +/- 14 days

Change in Kidney Disease Quality of Life (KDQOL-36) score across treatment arms. KDQOL-36 is scored on a 0-100 scale across five domains, with higher scores indicating better health-related quality of life.

Baseline to 26 weeks +/- 14 days
Health-Related Quality of Life - European Quality of Life 5 Dimensions, 5 Level (EQ-5D-5L) Questionnaire
Tidsramme: Baseline to 26 weeks +/- 14 days

Change in health-related quality of life measured using the European Quality of Life 5-Dimension, 5-Level questionnaire across treatment arms. A score of 11111 = no problems in any dimension (best), and a score of 55555 = extreme problems in all dimensions (worst).

Baseline to 26 weeks +/- 14 days
Change in Functional Status - Kidney Disease Quality of Life 36-Item Short form (KDQOL-36)
Tidsramme: Baseline to 26 weeks +/- 14 days

Change in functional status measured with KDQOL-36™ scores across treatment arms. KDQOL-36 is scored on a 0-100 scale across five domains, with higher scores indicating better health-related quality of life.

Baseline to 26 weeks +/- 14 days
Change in Functional Status - European Quality of Life five-dimensional, five-level generic measure (EQ-5D-5L) scores across treatment arms.
Tidsramme: Baseline to 26 weeks +/- 14 days

Measured via EQ-5D-5L (European Quality of Life five-dimensional, five-level generic measure) scores across treatment arms. A score of 11111 = no problems in any dimension (best), and a score of 55555 = extreme problems in all dimensions (worst).

Baseline to 26 weeks +/- 14 days
Weight Loss ≥5%
Tidsramme: Baseline to 26 weeks +/- 14 days

Percentage of participants achieving at least 5% reduction in body weight from baseline.

Baseline to 26 weeks +/- 14 days
Weight Loss ≥10%
Tidsramme: Baseline to 26 weeks +/- 14 days

Percentage of participant achieving at least 10% reduction in body weight from baseline.

Baseline to 26 weeks +/- 14 days
Weight Loss ≥15%
Tidsramme: 26 weeks +/- 14 days

Percentage of participants achieving at least 15% reduction in body weight from baseline.

26 weeks +/- 14 days
Weight Loss ≥20%
Tidsramme: Baseline to 26 weeks +/- 14 days

Percentage of participants achieving at least 20% reduction in body weight from baseline.

Baseline to 26 weeks +/- 14 days
Body Mass Index (BMI)
Tidsramme: Baseline to 26 weeks +/- 14 days

Change in BMI across treatment arms. Measured in kg/m²

Baseline to 26 weeks +/- 14 days
Body Surface Area (BSA)
Tidsramme: Baseline to 26 weeks +/- 14 days

Change in BSA across treatment arms. Measured in m².

Baseline to 26 weeks +/- 14 days
Body Mass Index <35 kg/m²
Tidsramme: Week 26 +/- 14 days

Percentage of participants achieving a BMI below <35 kg/m², corresponding to the specified weight-based threshold for transplant listing.

Week 26 +/- 14 days
Dalhousie Clinical Frailty Scale Rating
Tidsramme: Baseline to 26 weeks +/- 14 days

Change in Dalhousie Clinical Frailty Scale rating across treatment arms. The scale ranges from 1 (very fit) to 9 (terminally ill).

Baseline to 26 weeks +/- 14 days
SARC-F Score
Tidsramme: Baseline to 26 weeks +/- 14 days

Change in sarcopenia measured by SARC-F score across treatment arms. This questionnaire is scored out of 10, with a score of 4 or higher indicating probable sarcopenia.

Baseline to 26 weeks +/- 14 days
FRAIL Scale
Tidsramme: Baseline to 26 weeks +/- 14 days

Change in frailty measured by the FRAIL Scale across treatment arms. The scale scores five components - fatigue, resistance, ambulation, illnesses, and loss of weight - on a 0-5 scale, with 0 indicating robust, 1-2 pre-frail, and 3 or more indicating frailty.

Baseline to 26 weeks +/- 14 days
Acute Kidney Injury (AKI)
Tidsramme: Baseline to 26 weeks +/- 14 days

Incidence of AKI. AKI defined by KDIGO as creatinine ≥ 1.5x baseline within 7 days in non-dialysis participants

Baseline to 26 weeks +/- 14 days
Hypoglycemia
Tidsramme: Baseline to week 26 +/- 14 days

Incidence of hypoglycemia (blood glucose <4 mmol/L or time below target using continuous glucose monitoring)

Baseline to week 26 +/- 14 days
Gastrointestinal Symptoms
Tidsramme: Baseline to 26 weeks +/- 14 days

Incidence of gastrointestinal symptoms, including nausea, vomiting, constipation

Baseline to 26 weeks +/- 14 days
Acute Biliary Disease
Tidsramme: Baseline to 26 weeks +/- 14 days

Incidence of acute biliary disease.

Baseline to 26 weeks +/- 14 days
Acute Pancreatitis
Tidsramme: Baseline to 26 weeks +/- 14 days

Incidence of acute pancreatitis.

Baseline to 26 weeks +/- 14 days
Diabetic Retinopathy Interventions
Tidsramme: Baseline to 26 weeks +/- 14 days

Incidence of interventions for diabetic retinopathy

Baseline to 26 weeks +/- 14 days
Injection-site reactions
Tidsramme: Baseline to 26 weeks +/- 14 days

Incidence of injection-site reactions in the intervention arm.

Baseline to 26 weeks +/- 14 days
Malignant Neoplasms
Tidsramme: Baseline to 26 weeks +/- 14 days

Incidence of malignant neoplasms.

Baseline to 26 weeks +/- 14 days
Coaching Visit Adherence
Tidsramme: Baseline to 26 weeks +/- 14 days

Percentage of participants completing ≥4 of 6 coaching visits.

Baseline to 26 weeks +/- 14 days
Semaglutide Discontinuation
Tidsramme: Baseline to 26 weeks +/- 14 days

Percentage of participants discontinuing semaglutide in the intervention arm.

Baseline to 26 weeks +/- 14 days
Achievement of semaglutide dose ≥1.0 mg/week
Tidsramme: Week 26 +/- 14 days

Percentage of participants in the intervention group achieving a semaglutide dose of ≥1.0 mg/week.

Week 26 +/- 14 days
Achievement of Semaglutide Dose ≥2.0 mg/week
Tidsramme: 26 weeks +/- 14 days

Percentage of participants achieving a semaglutide dose of ≥2.0 mg/week

26 weeks +/- 14 days
Semaglutide Initiation in Usual Care
Tidsramme: Baseline to 26 weeks +/- 14 days

Percentage of usual care arm participants initiating semaglutide during the study period.

Baseline to 26 weeks +/- 14 days
Use of Semaglutide in Usual Care Participants
Tidsramme: Baseline to 26 weeks +/- 14 days

Percentage of participants using semaglutide in the usual care arm.

Baseline to 26 weeks +/- 14 days
Semaglutide Dose ≥1.0 mg/Week in Usual care Arm
Tidsramme: 26 weeks +/- 14 days

Percentage of usual care participants achieving semaglutide dose ≥1.0 mg/week

26 weeks +/- 14 days
Semaglutide Dose ≥2.0 mg/Week in Usual Care Arm
Tidsramme: 26 Weeks +/- 14 days

Percentage of usual care participants achieving semaglutide dose ≥2.0 mg/week

26 Weeks +/- 14 days
Body Fat Percentage Measured with Smart Scale
Tidsramme: Baseline to 26 weeks +/- 14 days

Change in body fat percentage among the subsample of intervention participants using the study smart scale.

Baseline to 26 weeks +/- 14 days
Muscle Mass Measured with Smart Scale
Tidsramme: Baseline to 26 weeks +/- 14 days

Measured in kilograms. Change in muscle mass among the subsample of intervention participants using the study smart scale.

Baseline to 26 weeks +/- 14 days
Intervention Costs
Tidsramme: Baseline to 26 weeks

The total cost of the intervention incurred by participants during the 26-week follow-up period, in Canadian dollars (CAD)

Baseline to 26 weeks
Out-of-pocket costs
Tidsramme: Baseline to 26 weeks

Total out-of-pocket costs incurred by participants during the 26-week study period-including costs directly related to the intervention. Measured in Canadian dollars (CAD)

Baseline to 26 weeks
Lost Productivity Costs
Tidsramme: Baseline to 26 weeks

Costs associated with productivity losses during the 26-week follow-up period, including costs directly related to the participant's health care and intervention. Measured in Canadian dollars (CAD)

Baseline to 26 weeks
Health care utilization costs
Tidsramme: Baseline to 26 weeks

Total costs associated with health care utilization during the study period, including physician visits, hospitalizations, emergency department visits, medications, allied health services. Measured in Canadian dollars (CAD) using provincial administrative health data.

Baseline to 26 weeks

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in HbA1c
Tidsramme: Baseline to 24 Months

Change in glycated hemoglobin among participants with diabetes across treatment arms.

Baseline to 24 Months
Hospitalization for Hyperglycemia
Tidsramme: Baseline to 24 Months

Incidence of hospitalization for hyperglycemia in participants with diabetes across treatment arms

Baseline to 24 Months
Hospitalization for hypoglycemia
Tidsramme: Baseline to 24 Months

Incidence of hospitalization for hypoglycemia in participants with diabetes across treatment arms.

Baseline to 24 Months
Initiation of Dialysis
Tidsramme: Baseline to 24 Months

Percentage of non-dialysis participants initiating dialysis across treatment arms

Baseline to 24 Months
Cardiovascular Composite
Tidsramme: Baseline to 24 Months

Composite of hospitalization for acute myocardial infarction, stroke, amputation, or heart failure across treatment arms.

Baseline to 24 Months
Kidney Transplantation
Tidsramme: Baseline to 24 months

Percentage of participants receiving kidney transplantation across treatment arms.

Baseline to 24 months
Healthcare utilization
Tidsramme: 24 months

Health care utilization over 24 months including number of hospital admissions, emergency department, outpatient and primary care visits, specialist visits, rehabilitation, allied health care visits. Measured using provincial administrative health data.

24 months
Health care costs
Tidsramme: 24 months

Health care costs over 24 months, including total health care costs, hospitalization-related costs, emergency department costs, outpatient and physician costs, medication costs. Measured in Canadian dollars (CAD) using provincial administrative health data.

24 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Etterforskere

  • Hovedetterforsker: Kristin Clemens, MD, St. Joseph's Health Care London, Western University
  • Hovedetterforsker: Louise Moist, MD, London Health Sciences Centre

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. januar 2027

Primær fullføring (Antatt)

1. januar 2029

Studiet fullført (Antatt)

1. januar 2029

Datoer for studieregistrering

Først innsendt

10. september 2026

Først innsendt som oppfylte QC-kriteriene

28. september 2026

Først lagt ut (Faktiske)

5. oktober 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • PIVOT

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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