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Clinical Trial Details

Trial ID: L2304
Source ID: NCT04741074
Associated Drug: Semaglutide 2 Mg/1.5 Ml (1.34 Mg/Ml), Prefilled Pen-Injector For Subcutaneous Injection Solution
Title: Effect of Subcutaneous Semaglutide on Kidney Transplant Candidacy
Acronym: RAISE-KT
Status: TERMINATED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT04741074/results
Conditions: CKD|Diabetic Kidney Disease|Type 2 Diabetes Mellitus in Obese|Obesity|Severe Obesity
Interventions: DRUG: Semaglutide 2 mg/1.5 ml (1.34 mg/ml), prefilled pen-injector for subcutaneous injection solution|DRUG: Placebo 1.5 ml, prefilled pen-injector for subcutaneous injection solution
Outcome Measures: Primary: Kidney Transplant Eligibility, Proportion either listed for kidney transplant at 9 months or meeting the following kidney transplant candidacy criteria for A1c (\<9%) and obesity (BMI \<35 kg/m2 or BMI 35-40 kg/m2 with waist circumference \<120 cm), Ascertained at the end of 9 months | Secondary: Change in Hemoglobin A1c (HgbA1c), HgbA1c will be collected using routine procedures and measured on the same day at the central Geisinger laboratory by Turbidimetric inhibition immunoassay., From baseline to 9 months|Change in BMI, Weight will be measured at each study visit in light clothing without shoes by trained, certified staff using a calibrated, digital scale. Scales will be calibrated annually. Height will be measured at the initial study visit to the nearest 0.1 cm using a calibrated, wall-mounted stadiometer without shoes on a firm, level surface, with head in the horizontal plane., From baseline to 9 months|Change in Waist Circumference, Waist circumference will be measured at each study visit to the nearest 0.1 cm using a Gulick II tape measure., From baseline to 9 months|Change in Waist-to-hip Ratio, Hip circumference will also be measured to the nearest 0.1 cm using a Gulick II tape measure, and waist-to-hip ratio will be calculated., From baseline to 9 months|Change in Body Fat Percentage, Measured using bioelectrical impedance analysis, From baseline to 9 months|New Activation on the Transplant List, Proportion of participants who were newly added to a transplant list during study period. Assessed by Geisinger kidney transplant committee (blinded to randomization assignment, independent of investigators), Assessed at end of 9 months|Receipt of Kidney Transplant, Confirmed by review of electronic health record (EHR), Assessed at end of 9 months | Other: Change in Low-Density Lipoprotein (LDL), Collected at a Geisinger lab using routine procedures and measured on the same day at the central Geisinger laboratory by spectrophotometry., Baseline to 9 months|Change in Triglycerides, Collected at a Geisinger lab using routine procedures and measured on the same day at the central Geisinger laboratory by spectrophotometry., Baseline to 9 months|Change in Systolic Blood Pressure, Automated office blood pressure (AOBP) will be measured (attended) using the OMRON 907-XL machine, with a 5-minute rest period in the seated position, followed by 3 measurements separated by 1-minute time intervals by trained research staff. Mid-arm circumference will be measured, and a cuff of appropriate size will be identified and the same size cuff will used for both visits., Baseline to 9 months|Change in Diastolic Blood Pressure, Automated office blood pressure (AOBP) will be measured (attended) using the OMRON 907-XL machine, with a 5-minute rest period in the seated position, followed by 3 measurements separated by 1-minute time intervals by trained research staff. Mid-arm circumference will be measured, and a cuff of appropriate size will be identified and the same size cuff will used for both visits., Baseline to 9 months|Change in Albuminuria Among Subset of Participants Without End-stage Kidney Disease, Testing at the central Geisinger laboratory, using immunoturbidimetry (albumin) and Jaffe/Enzymatic (Urine Creatinine), Baseline to 9 months|Change in Estimated Glomerular Filtration (eGFR) Rate Among Subset of Participants Without End-stage Kidney Disease, Testing at central Geisinger lab; Creatinine-based CKD-EPI equation, Baseline to 9 months|All-cause Hospitalizations, Collected using Geisinger EHR data, Entire 9-month study period|Cardiovascular Disease (CVD) Events, Collected using Geisinger EHR data using ICD codes for CVD-related hospitalizations, Entire 9-month study period|Proportion Experiencing Doubling of Creatinine or End-stage Kidney Disease, Collected using Geisinger EHR data using ICD codes, Entire 9-month study period|Proportion Experiencing Death, Collected using Geisinger EHR data, Entire 9-month study period|Proportion Experiencing Gastrointestinal Disorders, Assessed at each study visit, Entire 9-month study period|Proportion Experiencing Gallbladder Disorders, Assessed at each study visit, Entire 9-month study period|Proportion Experiencing Neoplasms, Assessed at each study visit, Entire 9-month study period|Proportion Experiencing Hepatic Events, Assessed at each study visit, Entire 9-month study period|Proportion Experiencing Allergic Reactions, Assessed at each study visit, Entire 9-month study period|Proportion Experiencing Injection-site Reactions, Assessed at each study visit, Entire 9-month study period|Proportion Experiencing Hypoglycemia Events, Assessed at each study visit, Entire 9-month study period|Proportion Experiencing Acute Pancreatitis Events, Assessed at each study visit, Entire 9-month study period
Sponsor/Collaborators: Sponsor: Geisinger Clinic
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 15
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2021-07-23
Completion Date: 2023-01-31
Results First Posted: 2024-02-09
Last Update Posted: 2024-02-09
Locations: Geisinger Medical Center, Danville, Pennsylvania, 17821, United States|Geisinger Wyoming Valley, Wilkes-Barre, Pennsylvania, 18702, United States
URL: https://clinicaltrials.gov/show/NCT04741074