Phase 3 · Semaglutide

RAISE-KT trial results

A RAndomized trIal Examining the Effect of Subcutaneous Semaglutide on Kidney Transplant Candidacy for Patients With Stage 4-5 CKD or Dialysis-dependent ESKD

Kidney Transplant Eligibility (Participants), Ascertained at the end of 9 months. Semaglutide: 3; Placebo: 2.

Participants
15
Status
terminated
Completed
2023-01-31
Sponsor
Geisinger Clinic

As posted on ClinicalTrials.gov (NCT04741074), updated at source Feb 9, 2024. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What RAISE-KT measured first

Kidney Transplant EligibilityParticipants · Ascertained at the end of 9 months · count of participants
Semaglutiden=5Placebon=7
32
Side effects by arm

Side effects in RAISE-KT

Percent of participants affected, 9 months. The most common events the registry lists.

EventSemaglutidePlacebo
Any serious event28.6%37.5%
Hypoglycemia events42.9%50%
Gastrointestinal disorders28.6%25%
Foot ulcer14.3%0%
Anemia or bleeding disorder0%12.5%
shortness of breath0%12.5%
Hypertension0%12.5%
Gallbladder disorders0%0%
Neoplasms0%0%
Hepatic events0%0%
Allergic reactions0%0%
Injection-site reactions0%0%
Acute pancreatitis0%0%
Secondary outcomes

What else it measured

Change in Hemoglobin A1c (HgbA1c)Percentage of glycosylated hemoglobin · From baseline to 9 months · mean
Semaglutiden=5Placebon=7
-1.10(1.03)0.33(0.78)
Change in BMIkg/m^2 · From baseline to 9 months · mean
Semaglutiden=5Placebon=7
-2.55(4.25)-.07(2.70)
Change in Waist Circumferencecm · From baseline to 9 months · mean
Semaglutiden=5Placebon=7
-0.52(14.38)3.91(6.32)
Change in Waist-to-hip Ratiocm/cm · From baseline to 9 months · mean
Semaglutiden=5Placebon=7
-.00(0.11)0.03(0.05)
Change in Body Fat PercentageBody fat percentage · From baseline to 9 months · mean
Semaglutiden=6Placebon=5
-2.70(1.93)0.13(3.98)
New Activation on the Transplant ListParticipants · Assessed at end of 9 months · count of participants
Semaglutiden=5Placebon=7
30
Receipt of Kidney TransplantParticipants · Assessed at end of 9 months · count of participants
Semaglutiden=5Placebon=7
00
The trial

How RAISE-KT was run

This randomized study evaluates the effect of subcutaneous semaglutide /in combination with lifestyle counseling in patients with type 2 diabetes mellitus (T2DM), overweight/obesity, and stage 4-5 chronic kidney disease (CKD) or dialysis-dependent end-stage kidney disease (ESKD) on patients' eligibility for kidney transplantation at the end of 9 months.

  • Semaglutide: This arm will receive semaglutide.
  • Placebo: This arm will receive placebo.
Who could join the trial

Inclusion Criteria: 1. \- Age ≥ 18 years 2. \- BMI 25-45 kg/m2 3. \- T2DM 4. \- Advanced CKD\* (last eGFR \<30 ml/min/1.73m2 in EHR or ESKD on dialysis prior to screening) or stage G3B/A2-3 CKD (eGFR 30 to \<45 ml/min/1.73m2 with albumin/creatinine ratio \>30 mg/g). 5. \- Fulfill kidney transplant listing criteria except for one or more of the following reasons (1: uncontrolled diabetes \[A1c ≥9%); 2: severe obesity (BMI ≥ 40 kg/m2 or BMI 35-40 kg/m2 with waist circumference \>120 cm). See exclusion criteria for general contraindications used for transplant listing used by majority of U.S. transplant centers\]. 6. \- Ability to provide informed consent before any trial-related activities 7. \- Access to a telephone * The cause of the CKD does not need to be due specifically to diabetes Exclusion Criteria (General contraindications used for transplant listing used by majority of U.S. transplant centers) 1. \- Active malignancy 2. \- History of pancreatitis 3. \- Active substance abuse 4. \- Severe COPD 5. \- Pulmonary fibrosis 6. \- Symptomatic angina or recent myocardial infarction within 6 months 7. \- Severe peripheral vascular disease 8. \- Cirrhosis 9. \- New York Health Association (NYHA) Class III-IV congestive heart failure 10. \- Severe cognitive impairment 11. \- Drug addiction 12. \- History of non-adherence to therapy 13. \- Active infection 14. \- Expected life expectancy \< 5 years Additional exclusion criteria 15. \- Type 1 diabetes mellitus 16. \- History of diabetic ketoacidosis within the last 12 months 17. \- Planning on undergoing bariatric surgery in next 9 months. 18. \- Pregnant, breast-feeding, or planned pregnancy prior to the end of participation or not using adequate contraceptive measures 19. \- Self-reported average consumption of \> 21 alcoholic beverages per week or binge drinking 20. \- Psychiatric hospitalization in past year 21. \- Principal investigator discretion (i.e. concerns about safety, compliance) 22. \- Known or suspected allergy to trial medication 23. \- Previous participation (i.e. randomized) in this trial 24. \- Use of GLP1-RA or pramlintide within 90 days prior to screening 25. \- Use of metformin (contraindicated with eGFR \< 30 ml/min/1.73m2) 26. \- Use of DPP-4 inhibitors within 30 days prior to screening 27. \- Personal or family history of medullary thyroid cancer, multiple endocrine neoplasia types 2A and 2B syndrome 28. \- Last hemoglobin A1c ≥ 12% or A1c \<6% (to avoid risk of hypoglycemia) prior to screening

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

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