2024-518774-14-00招募中2 期
SGL-TX-PTDM: SGLT2i effect on PTDM development and kidney allograft function in kidney transplant recipients: A randomized, double-blind, placebo controlled, national multicenter trial
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 184
- 试验地点
- 3
- 主要终点
- • Post Transpalnt Diabetes Mellitus incidence after 6 and 12 months follow-up
研究概览
简要总结
Determine the effect of oral SGLT2i compared with placebo as add-on to standard-of-care on PTDM incidence in non-diabetic KTR.
研究设计
- 分配方式
- Randomized
- 主要目的
- From first participant first visit (FPFV) to last participant last visit (LPLV)
- 盲法
- Double (Investigator, Subject, Carer, Analyst, Monitor)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 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 Kidney Transplant Recipient
- •eGFR> 25 ml/min/1.73m2 within the last 3 months pre randomization
- •Immunosuppressive must include Tacrolimus
排除标准
- •Patients who is 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
- •Positive plasma hCG
- •Breastfeeding
- •Known allergy towards SGLT2i or the content substance
- •Patients with chronic intestinal diseases, including inflammatory bowel diseases (e.g., Crohn’s disease and ulcerative colitis) and structural conditions such as short bowel syndrome.
研究组 & 干预措施
Forxiga 10 mg film-coated tablets
Test
干预措施: Forxiga 10 mg film-coated tablets (Drug)
The placebo medicinal product is manufactured by the Capital Region Hospital Pharmacy (Region Hovedstadens Apotek). The placebo tablet is white, round, and biconvex, with a diameter of 8 mm. It consists of lactose monohydrate, potato starch, gelatin A, purified water, magnesium stearate (MF2V), and talc. The tablets are over-encapsulated in an opaque hard gelatin capsule identical in appearance to the capsule containing the active Forxiga® tablet. For further details, please refer to document G1_sIMPD_Q Placebo.
Placebo
干预措施: The placebo medicinal product is manufactured by the Capital Region Hospital Pharmacy (Region Hovedstadens Apotek). The placebo tablet is white, round, and biconvex, with a diameter of 8 mm. It consists of lactose monohydrate, potato starch, gelatin A, purified water, magnesium stearate (MF2V), and talc. The tablets are over-encapsulated in an opaque hard gelatin capsule identical in appearance to the capsule containing the active Forxiga® tablet. For further details, please refer to document G1_sIMPD_Q Placebo. (Drug)
结局指标
主要结局
• Post Transpalnt Diabetes Mellitus incidence after 6 and 12 months follow-up
• Post Transpalnt Diabetes Mellitus incidence after 6 and 12 months follow-up
次要结局
- Prediabetes incidence after 6 and 12 month follow-up
- eGFR change after 6 and 12 month follow up.
- Proteinuria determined by Albumin/creatinine ratio (U-ACR) (mg/g)
- Change in creatinine and Cholesterol after 6 and 12 month follow-up
- Incidence og urinaty tract infection determined by (positive urine culture)
- Incidence of kidney transplant rejection (biopsy verified)
- Incidence of serious adverse reactions
- Renal composite outcome o Incidence of graft failure (defined as return to dialysis or retransplantation) o Incidence of ESRD (defined as eGFR<15 ml/min/1.73m2) o Incidence of > 25% increase in creatinine
- Change in Systolic blood pressure (SysBP) (mmHg) and diastolic blood pressure (DiaBP) (mmHg)
- Relative incidence of out-of-target measures of clinical routine blood Tacrolimus levels
- Urine biomarkers indicative of podocyt and tubular function from selected sites
- Incidence of Adverse events
- Incidence of Serious adverse events
- Incidence of death (all cause mortality)
- Incidence of Major Adverse Cardiac Events (MACE)
- Change in score for Short Form Health Survey 36 between baseline and after 12 month follow-up
研究者
Lotte Borg Lange
Scientific
Odense University Hospital
研究点 (3)
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