Primary outcomeCount of participants· Ascertained at the end of 9 months
Kidney Transplant Eligibility
| Group | Value (Participants) |
|---|---|
| Semaglutide | 3 |
| Placebo | 2 |
Trial · Interventional
TerminatedPhase 3Results postedRegistry dataEffect of Subcutaneous Semaglutide on Kidney Transplant Candidacy
Short name RAISE-KT
NCTNCT04741074 (opens ClinicalTrials.gov in a new tab)Other id2020-1050Other idUniversal Trial Number
This trial was stopped early.
Reason given at the registry: low recruitment
Results were posted for this trial.
Overview
- Status
- Terminated
- Phase
- Phase 3
- Enrollment
- 15 participants (actual)
- Sponsor
- Geisinger Clinic · Other
- Design
- Randomized · Quadruple masking
- Countries
1 country
United States
- Start
- 23 Jul 2021
- Primary completion
- 31 Jan 2023
- Completion
- 31 Jan 2023
- First posted
- 5 Feb 2021
- Last update posted
- 9 Feb 2024
- Conditions
- CKD · Diabetic Kidney Disease · Type 2 Diabetes Mellitus in Obese · Obesity · Severe Obesity
Timeline
1 trial · 1 stopped early · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2021202220232024
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- Semaglutide 2 mg/1.5 ml (1.34 mg/ml), prefilled pen-injector for subcutaneous injection solutionDrug
- Placebo 1.5 ml, prefilled pen-injector for subcutaneous injection solutionDrug
Arms2
Active comparator
Semaglutide
This arm will receive semaglutide.
Placebo comparator
Placebo
This arm will receive placebo.
Primary outcomes1
Outcomes the sponsor listed as primary.
Kidney Transplant Eligibility
Time frame · Ascertained at the end of 9 months
Registry description
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)
Secondary outcomes(7)
Change in Hemoglobin A1c (HgbA1c)
Time frame · From baseline to 9 months
Registry description
HgbA1c will be collected using routine procedures and measured on the same day at the central Geisinger laboratory by Turbidimetric inhibition immunoassay.
Change in BMI
Time frame · From baseline to 9 months
Registry description
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.
Change in Waist Circumference
Time frame · From baseline to 9 months
Registry description
Waist circumference will be measured at each study visit to the nearest 0.1 cm using a Gulick II tape measure.
Change in Waist-to-hip Ratio
Time frame · From baseline to 9 months
Registry description
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.
Change in Body Fat Percentage
Time frame · From baseline to 9 months
Registry description
Measured using bioelectrical impedance analysis
New Activation on the Transplant List
Time frame · Assessed at end of 9 months
Registry description
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)
Receipt of Kidney Transplant
Time frame · Assessed at end of 9 months
Registry description
Confirmed by review of electronic health record (EHR)
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(7)
Secondary outcomeMean· From baseline to 9 months
Change in Hemoglobin A1c (HgbA1c)
| Group | Value (Percentage of glycosylated hemoglobin) | Spread |
|---|---|---|
| Semaglutide | -1.10 | 1.03 |
| Placebo | 0.33 | 0.78 |
Secondary outcomeMean· From baseline to 9 months
Change in BMI
| Group | Value (kg/m^2) | Spread |
|---|---|---|
| Semaglutide | -2.55 | 4.25 |
| Placebo | -.07 | 2.70 |
Secondary outcomeMean· From baseline to 9 months
Change in Waist Circumference
| Group | Value (cm) | Spread |
|---|---|---|
| Semaglutide | -0.52 | 14.38 |
| Placebo | 3.91 | 6.32 |
Secondary outcomeMean· From baseline to 9 months
Change in Waist-to-hip Ratio
| Group | Value (cm/cm) | Spread |
|---|---|---|
| Semaglutide | -.00 | 0.11 |
| Placebo | 0.03 | 0.05 |
Secondary outcomeMean· From baseline to 9 months
Change in Body Fat Percentage
| Group | Value (Body fat percentage) | Spread |
|---|---|---|
| Semaglutide | -2.70 | 1.93 |
| Placebo | 0.13 | 3.98 |
Secondary outcomeCount of participants· Assessed at end of 9 months
New Activation on the Transplant List
| Group | Value (Participants) |
|---|---|
| Semaglutide | 3 |
| Placebo | 0 |
Secondary outcomeCount of participants· Assessed at end of 9 months
Receipt of Kidney Transplant
| Group | Value (Participants) |
|---|---|
| Semaglutide | 0 |
| Placebo | 0 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| SemaglutideThis arm will receive semaglutide. Semaglutide 2 mg/1.5 ml (1.34 mg/ml), prefilled pen-injector for subcutaneous injection solution: Dose will be started at 0.25 mg per week. Dose escalation will occur every 4 weeks to mitigate risk of gastrointestinal side effects to a maximum dose of 1.0 mg per week. | 0 / 7 | 2 / 7 | 5 / 7 |
| PlaceboThis arm will receive placebo. Placebo 1.5 ml, prefilled pen-injector for subcutaneous injection solution: Matched placebo solution for injection will be provided by Novo Nordisk in a 1.5 ml pre-filled pen-injector for subcutaneous injection with the same instructions on dose escalation. | 0 / 8 | 3 / 8 | 8 / 8 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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
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