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Trial · Interventional

Not yet recruitingPhase 4Registry data

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

Short name PIVOT

NCTNCT07858331 (opens ClinicalTrials.gov in a new tab)Other idPIVOT
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Not yet recruiting
Phase
Phase 4
Enrollment
880 participants (estimated)
Sponsor
Kristin Clemens · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Canada

Start
1 Jan 2027 (estimated)
Primary completion
1 Jan 2029 (estimated)
Completion
1 Jan 2029 (estimated)
First posted
5 Oct 2026
Last update posted
5 Oct 2026
Conditions
Obesity · Chronic Kidney Disease · Chronic Renal Disease · CKD

Timeline

1 trial · 1 not yet recruiting

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2027202820292030
  1. Ph 4

    PIVOT

    NCT07858331

    est. 1 Jan 2027 to est. 1 Jan 2029

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • SemaglutideDrug
  • Virtual Weight Management CoachingBehavioral

Arms2

  • 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.

  • No intervention

    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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in Body Weight

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

    Registry description

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

Secondary outcomes(20)

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

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

    Registry description

    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.

  2. 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

    Registry description

    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).

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

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

    Registry description

    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.

  4. 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

    Registry description

    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).

  5. Weight Loss ≥5%

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

    Registry description

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

  6. Weight Loss ≥10%

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

    Registry description

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

  7. Weight Loss ≥15%

    Time frame · 26 weeks +/- 14 days

    Registry description

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

  8. Weight Loss ≥20%

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

    Registry description

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

  9. Body Mass Index (BMI)

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

    Registry description

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

  10. Body Surface Area (BSA)

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

    Registry description

    Change in BSA across treatment arms. Measured in m².

  11. Body Mass Index <35 kg/m²

    Time frame · Week 26 +/- 14 days

    Registry description

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

  12. Dalhousie Clinical Frailty Scale Rating

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

    Registry description

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

  13. SARC-F Score

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

    Registry description

    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.

  14. FRAIL Scale

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

    Registry description

    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.

  15. Acute Kidney Injury (AKI)

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

    Registry description

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

  16. Hypoglycemia

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

    Registry description

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

  17. Gastrointestinal Symptoms

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

    Registry description

    Incidence of gastrointestinal symptoms, including nausea, vomiting, constipation

  18. Acute Biliary Disease

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

    Registry description

    Incidence of acute biliary disease.

  19. Acute Pancreatitis

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

    Registry description

    Incidence of acute pancreatitis.

  20. Diabetic Retinopathy Interventions

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

    Registry description

    Incidence of interventions for diabetic retinopathy

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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