Tirzepatide Study of Renal Function in People with Overweight or Obesity and Chronic Kidney Disease with or without Type 2 Diabetes: Focus on Kidney Hypoxia in Relation to Fatty Kidney Disease using Multiparametric Magnetic Resonance Imaging (TREASURE-CKD)
- Conditions
- 1001842410038430metabolism and nutrition disordersObesity and overweightChronic kidney disease and kidney disease
- Registration Number
- NL-OMON51386
- Lead Sponsor
- Eli Lilly
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 16
1. Participants without diabetes must have HbA1c of <= 6.5 %.
2. Participants with diabetes must have HbA1c >= 7 % to <= 10.5 % at screening
visit.
3. Participants must be at least 18 years of age or the legal age of consent in
the jurisdiction where the study is taking place.
4. Participants must have a BMI >= 27kg/cm2 at screening visit.
5. Participants must be diagnosed with CKD having a eGFR >=30 to <= 60 mL/min1.73
m2 or eGFR >= 30 to 75 mL/min/1.73 m2 if UACR > 30 mg/g, calculated by CKD-EPI
equation, as determined by central labs at screening visit.
6. Participants must have been receiving an ACE or ARBi that is considered the
maximal appropriate dose by the investigator for treatment of CKD or
hypertension (unless patient has low blood pressure or hypotension). The dose
must have been unchanged for 30 days before screening visit.
For participants with T2D the following exclusion criteria apply:
1. Participants have a history of proliferative diabetic retinopathy or
diabetic macular edema or non-proliferative edema or non-proliferative diabetic
retinopathy that requires acute treatment.
2. Participants who have uncontrolled diabetes (such as diabetic ketoacidosis)
at screening or randomization, in the judgement of the physician.
For participants without T2D the following exclusion criteria apply:
3. Have T1DM or a history of ketoacidosis ot hypersmolar state/coma
4. Have self reported change in body weight >5kgs within the 90 days prior to
screening visit
5. Have had or plan to have surgical treatment for obesity (excluding
liposuction or abdominoplasty if performed >1 year prior to screening)
6. Have or plan to have endoscopic and or device based therapy for obesity or
have had device removal within the last 180 days e.g. mucosal ablation, gastric
artery embolization, intragastric balloon and duodenal jejunal bypass device.
7. Have eGFr < 30 mL/min/1.73 m2 calculated by CKD-EPI equation.
8. Have a history of unstable or rapidly progressing renal disease according to
investigator judgement.
9. Have a history of a congenital or hereditary kidney disease, like polycystic
kidney disease or congenital urinary tract malformations
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Following parameters will be determined to compare the effect of tirzepatide<br /><br>MTD (10 or 15 mg) once a week and placebo after 52 weeks of treatment in<br /><br>participants with and without T2D:<br /><br>- kidney oxygenation</p><br>
- Secondary Outcome Measures
Name Time Method <p>Following parameters will be determined to compare the effect of tirzepatide<br /><br>MTD (10 or 15 mg) once a week and placebo after 52 weeks of treatment in<br /><br>participants with and without T2D:<br /><br>- body weight<br /><br>- renal sinus fat<br /><br>- renal fat content<br /><br>- renal blood flow<br /><br>- kidney apparent diffusion coefficient<br /><br>- glomerular filtration rate<br /><br>- urinary albumin excretion<br /><br>- urine albumin-to-creatinine ratio<br /><br>- kidney inflammation<br /><br>- kidney oxidative metabolism<br /><br>- fractional urinary sodium excretion<br /><br>- 24-hour sodium excretion<br /><br>- waist circumference<br /><br>- blood pressure<br /><br>- heart rate<br /><br>- HbA1c and CRP<br /><br>- lipids<br /><br>- health-related quality of life<br /><br>- mitochondrial function</p><br>