Obesity Management for Kidney TRANSPLANTation: a Vanguard Study for an Innovative Randomized Controlled Trial, Embedded in Routine Care (OK-TRANSPLANT 2)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Feasibility of Recruitment
研究概览
简要总结
OK-TRANSPLANT 2 is a vanguard study for a large randomized, pragmatic, open-label trial.
We will randomize participants with obesity, high-risk CKD/dialysis who are hoping for lose weight for the purpose of kidney transplant. Subjects will either be enrolled on a virtual weight management program or continue their usual care.
详细描述
Obesity is well-recognized as an independent risk factor for chronic kidney disease (CKD) including end-staged kidney disease (ESKD). In people with ESKD, obesity can preclude access to lifesaving kidney transplantation. Of solid organ transplant programs in Canada, 80% exclude people with obesity (based upon body mass index or BMI), due to a potential risk of perioperative complications and post-transplant mortality.
Losing weight for kidney transplantation can, however, be extremely difficult. Medications that can promote weight loss in other populations including glucagon-like peptide 1 receptor agonists (GLP-1RA; liraglutide, semaglutide, and dulaglutide) and glucose-dependent insulinotropic polypeptide (GIP-1RA)/GLP-1RAs (tirzepatide), have not been studied in devoted trials of advanced CKD participants, and their efficacy and safety remain unclear.
Nutritional advice is often very difficult to follow when trying to balance kidney and diabetes diets (e.g. potassium), and if diets are too restrictive, there may be protein-energy wasting which could be detrimental to patients. People with high-risk CKD frequently live with functional impairment which can limit exercise. Weight loss programs can be cost prohibitive to those who are already socioeconomically disadvantaged.
A vanguard is needed before a large, multicentered RCT: A feasibility study will allow us to ensure that we can recruit a sufficient sample of participants into our trial, that our trial processes are inclusive, and that they are acceptable to patients. In the vanguard phase of our trial, we will answer the following questions:
- Is participant recruitment into a large multi-centered trial feasible?
- Will participants remain adherent to their assigned treatment arm over 26 weeks of study?
- Will participants find our program acceptable?
- Will safety events preclude us from testing our intervention in a larger RCT?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Double: Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older
- •BMI; 35 kg/m^2
- •10% risk of ESKD requiring renal replacement therapy over 2 years or receiving dialysis
排除标准
- •Known contraindication to a GLP-1RA (pancreatitis, personal or family history of medullary thyroid cancer, hypersensitivity)
- •Type 1 diabetes
- •No access to semaglutide via drug coverage
- •Pregnant, breastfeeding or planning to become pregnant
- •Currently in a GLP-1RA or GLP-1RA/GIP study or planning to be in one
研究组 & 干预措施
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.
Virtual Weight Management Program
A maximum tolerated dose of semaglutide (Ozempic/Wegovy) 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.
干预措施: Virtual Weight Management Coaching (Behavioral)
Virtual Weight Management Program
A maximum tolerated dose of semaglutide (Ozempic/Wegovy) 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.
干预措施: Semaglutide (Drug)
结局指标
主要结局
Feasibility of Recruitment
时间窗: 12 months
Number of participants enrolled across three centers, with success defined as recruitment of ≥ 60 participants within the 12-month enrollment period.
次要结局
- Recruitment Per Site Within 12 Weeks(First 12 weeks)
- Incidence of Acute Kidney Injury(12 months)
- Incidence of Hypoglycemia(12 months)
- Incidence of Gastrointestinal Side Effects(12 months)
- In-Clinic Weight Measurement(Baseline, 3 months, 6 months)
- In-Clinic Body Mass Index Measurement(Baseline, 3 months, 6 months)
- In-Clinic Height Measurement(Baseline, 3 months, 6 months)
- Adherence to Scheduled Coaching Visits(12 months)
- Adherence to GLP-1RA Therapy(12 months)
- Recruitment of ≥20 Participants in First 12 Weeks(First 12 weeks)
- Change in Dalhousie Clinical Frailty Scale Classification(26 weeks)
- Change in SARC-F Score of Sarcopenia(26 weeks)
- Change in Body Weight - Smart Scale(26 weeks)
- Change in Body Fat - Smart Scale(26 weeks)
- Change in Muscle Mass - Smart Scale(26 weeks)
- Change in Body Water Content - Smart Scale(26 weeks)
研究者
Kristin Clemens
Associate Professor
Western University, Canada