SGLT2i Safety and Efficacy on Kidney Allograft Function in Non-diabetic Kidney Transplant Recipients: A Randomized, Double-blind, Placebo Controlled, National, Multicenter Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Kidney transplant function
研究概览
简要总结
This clinical trial investigates whether 18 months of daily SGLT2i (10 mg Forxiga) preserves kidney function and evaluates safety, based on eGFR changes and adverse event occurrence in non-diabetic kidney transplant recipients.
The main questions it aims to answer are:
- Does SGLT2i versus placebo, as an add-on to standard care, preserve kidney transplant function in non-diabetic recipients?
- Is SGLT2i treatment safe for non-diabetic transplant recipients when evaluating adverse events?
- Does SGLT2i versus placebo affect the occurrence of urinary tract infections, post-transplant diabetes mellitus (PTDM) and prediabetes incidence, U-ACR, as well as renal and cardiovascular parameters?
Researchers will compare a daily dose of SGLT2i (10 mg Forxiga) with a placebo (a look-alike tablet with no active medicine).
Kidney transplant recipients who do not have diabetes can take part if they meet the study's requirements. Participants will be randomly assigned to receive either Forxiga or placebo once daily for 18 months. All participants will have check-ups every 3 months, which will include urine tests and blood samples. Neither the participants nor the study doctors will know which treatment they are receiving.
详细描述
Background:
Kidney transplantation is the best treatment for end-stage renal disease (ESRD), although the median allograft survival is only 15 years. In non-transplant patients with chronic kidney disease (CKD), sodium-glucose co-transporter type 2 inhibitors (SGLT2i) protect kidney function and slow the decline in estimated glomerular filtration rate (eGFR).
With the current kidney transplant survival of approximately 15 years, about one in ten adult kidney transplant recipients (KTR) outlive their donated kidneys. This poses a significant burden on both patients and society, increasing the demand for new transplantations. WHO reported a 9% increase in the number of kidney transplant recipients from 2022 to 2023. Therefore, research aimed at extending the functional lifespan of kidney transplants is crucial.
The efficacy of SGLT2i in KTR remains untested, and safety concerns persist, particularly regarding their impact on kidney transplant function. This study aims to investigate the safety and efficacy of this new class of anti-diabetic drugs (SGLT2i) on kidney transplant function. In the long-term, the investigators hope to contribute knowledge that will help preserve kidney transplant function, benefit society, and improve patients' quality of life.
Hypothesis:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, 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
- •Obtained written informed consent
- •Male or female patients, age ≥ 18 years.
- •Non-diabetic KTR
- •> 6 months post-transplant
- •eGFR> 25 ml/min/1.73m2 within the last 3 months pre randomization
- •Immunosuppressive must include Tacrolimus
- •Negative plasma hCG in fertile women*, and acceptance of the use of contraception during the course of the study.
排除标准
- •Patients treated (diet or antidiabetics) for diabetes type 1 or 2 before randomization
- •eGFR< 25 ml/min/1.73m2 (before randomization)
- •Alanine aminotransferase (ALAT) > 3 x upper normal limit
- •Bilirubin > 2 x upper normal limit
- •Pregnancy
- •Breastfeeding
- •Known allergy towards SGLT2i or the content substance
- •Known intestinal bowel disease
研究组 & 干预措施
SGLT2i
Daily dose of SGLT2i (Forxiga 10 mg tablet)
干预措施: SGLT-2 inhibitor (Drug)
Placebo
Daily dose of placebo tablet
干预措施: Placebo (Drug)
结局指标
主要结局
Kidney transplant function
时间窗: Measured from week 4, and then every 3. month until 18. month post randomization.
Chronic eGFR slope (ml/min/1.73m2)
次要结局
- Incidence of PTDM and prediabetes status(Measured from week 4, and then every 3. month until 18. month post randomization.)