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

28 de setembro de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

880

Estágio

  • Fase 4

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.
Medicamento: Semaglutide

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

Outros nomes:
  • Ozempic
  • Wegovy
  • Generic Semaglutide
  • Apo-Semaglutide
  • Semaglutide Injection
Comportamental: Virtual Weight Management Coaching

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.

Outros nomes:
  • Controle de peso
  • Coaching
Sem intervenção: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in Body Weight
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Quality of Life - Kidney Disease Quality of Life 36-Item Short Form
Prazo: 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
Prazo: 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)
Prazo: 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.
Prazo: 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%
Prazo: 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%
Prazo: 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%
Prazo: 26 weeks +/- 14 days

Percentage of participants achieving at least 15% reduction in body weight from baseline.
26 weeks +/- 14 days
Weight Loss ≥20%
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: Baseline to 26 weeks +/- 14 days

Incidence of gastrointestinal symptoms, including nausea, vomiting, constipation
Baseline to 26 weeks +/- 14 days
Acute Biliary Disease
Prazo: Baseline to 26 weeks +/- 14 days

Incidence of acute biliary disease.
Baseline to 26 weeks +/- 14 days
Acute Pancreatitis
Prazo: Baseline to 26 weeks +/- 14 days

Incidence of acute pancreatitis.
Baseline to 26 weeks +/- 14 days
Diabetic Retinopathy Interventions
Prazo: Baseline to 26 weeks +/- 14 days

Incidence of interventions for diabetic retinopathy
Baseline to 26 weeks +/- 14 days
Injection-site reactions
Prazo: Baseline to 26 weeks +/- 14 days

Incidence of injection-site reactions in the intervention arm.
Baseline to 26 weeks +/- 14 days
Malignant Neoplasms
Prazo: Baseline to 26 weeks +/- 14 days

Incidence of malignant neoplasms.
Baseline to 26 weeks +/- 14 days
Coaching Visit Adherence
Prazo: Baseline to 26 weeks +/- 14 days

Percentage of participants completing ≥4 of 6 coaching visits.
Baseline to 26 weeks +/- 14 days
Semaglutide Discontinuation
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Change in HbA1c
Prazo: Baseline to 24 Months

Change in glycated hemoglobin among participants with diabetes across treatment arms.
Baseline to 24 Months
Hospitalization for Hyperglycemia
Prazo: Baseline to 24 Months

Incidence of hospitalization for hyperglycemia in participants with diabetes across treatment arms
Baseline to 24 Months
Hospitalization for hypoglycemia
Prazo: Baseline to 24 Months

Incidence of hospitalization for hypoglycemia in participants with diabetes across treatment arms.
Baseline to 24 Months
Initiation of Dialysis
Prazo: Baseline to 24 Months

Percentage of non-dialysis participants initiating dialysis across treatment arms
Baseline to 24 Months
Cardiovascular Composite
Prazo: 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
Prazo: Baseline to 24 months

Percentage of participants receiving kidney transplantation across treatment arms.
Baseline to 24 months
Healthcare utilization
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Kristin Clemens

Investigadores

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

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de janeiro de 2027

Conclusão Primária (Estimado)

1 de janeiro de 2029

Conclusão do estudo (Estimado)

1 de janeiro de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

10 de setembro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

28 de setembro de 2026

Primeira postagem (Real)

5 de outubro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

5 de outubro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

28 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • PIVOT

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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