CKDPhase 3RAISE-KTNCT04741074
Effect of Subcutaneous Semaglutide on Kidney Transplant Candidacy
A Phase 3 study testing Semaglutide 2 mg/1.5 ml (1.34 mg/ml), prefilled pen-injector for subcutaneous injection solution in people with CKD and Diabetic Kidney Disease, run by Geisinger Clinic at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CKD, Diabetic Kidney Disease, Type 2 Diabetes Mellitus in Obese
- What is being tested?
- Semaglutide 2 mg/1.5 ml (1.34 mg/ml), prefilled pen-injector for subcutaneous injection solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Jul 2021to 31 Jan 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - Age ≥ 18 years
- - BMI 25-45 kg/m2
- - T2DM
- - 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).
- - 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].
- - Ability to provide informed consent before any trial-related activities
Show all 38Show fewer
- - 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)
- - Active malignancy
- - History of pancreatitis
- - Active substance abuse
- - Severe COPD
- - Pulmonary fibrosis
- - Symptomatic angina or recent myocardial infarction within 6 months
- - Severe peripheral vascular disease
- - Cirrhosis
- - New York Health Association (NYHA) Class III-IV congestive heart failure
- - Severe cognitive impairment
- - Drug addiction
- - History of non-adherence to therapy
- - Active infection
- - Expected life expectancy < 5 years
- Additional exclusion criteria
- - Type 1 diabetes mellitus
- - History of diabetic ketoacidosis within the last 12 months
- - Planning on undergoing bariatric surgery in next 9 months.
- - Pregnant, breast-feeding, or planned pregnancy prior to the end of participation or not using adequate contraceptive measures
- - Self-reported average consumption of > 21 alcoholic beverages per week or binge drinking
- - Psychiatric hospitalization in past year
- - Principal investigator discretion (i.e. concerns about safety, compliance)
- - Known or suspected allergy to trial medication
- - Previous participation (i.e. randomized) in this trial
- - Use of GLP1-RA or pramlintide within 90 days prior to screening
- - Use of metformin (contraindicated with eGFR < 30 ml/min/1.73m2)
- - Use of DPP-4 inhibitors within 30 days prior to screening
- - Personal or family history of medullary thyroid cancer, multiple endocrine neoplasia types 2A and 2B syndrome
- - Last hemoglobin A1c ≥ 12% or A1c <6% (to avoid risk of hypoglycemia) prior to screening
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Geisinger Medical Center
Danville, Pennsylvania, 17821
Geisinger Wyoming Valley
Wilkes-Barre, Pennsylvania, 18702
About this study
Official title: A RAndomized trIal Examining the Effect of Subcutaneous Semaglutide on Kidney Transplant Candidacy for Patients With Stage 4-5 CKD or Dialysis-dependent ESKD
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.
Read the detailed description
Transplant policies regarding listing consider uncontrolled diabetes and severe obesity to be contraindications though there is great variability for exact BMI (35-45 kg/m2) and A1c (9-10%) thresholds for listing by center. Glucagon-lowering peptide-1 receptor agonists (GLP-1 RAs) offer great promise in this population as they have been shown to reduce weight, central adiposity, A1c, and risk of cardiovascular outcomes with similar effects in patients with and without CKD.
In this double-blind, placebo-controlled randomized controlled trial, the investigators will evaluate the effect of subcutaneous semaglutide 1.34 mg/ml (up to 1.0 mg per week) in combination with lifestyle counseling in patients with T2DM, overweight/obesity, and stage 4-5 CKD or dialysis-dependent ESKD on patients' eligibility for kidney transplantation in terms of diabetes control (A1c <9%) and obesity (BMI <35 kg/m2 or 35-40 kg/m2 with waist circumference <120 cm) at the end of 9 months.
- Being tested
- Semaglutide 2 mg/1.5 ml (1.34 mg/ml), prefilled pen-injector for subcutaneous injection solution, Placebo 1.5 ml, prefilled pen-injector for subcutaneous injection solution
- Keywords
- ckd, obesity, kidney transplant, transplant wait list, diabetic kidney disease, glp-1, semaglutide
- Medical subject headings
- Diabetic Nephropathies, Obesity, Obesity, Morbid, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide 2 mg/1.5 ml (1.34 mg/ml), prefilled pen-injector for subcutaneous injection solutionDrug
Also called semaglutide
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.
Placebo 1.5 ml, prefilled pen-injector for subcutaneous injection solutionDrug
Also called placebo
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.
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide | Active comparator | This arm will receive semaglutide. Receives: Drug: Semaglutide 2 mg/1.5 ml (1.34 mg/ml), prefilled pen-injector for subcutaneous injection solution |
| Placebo | Placebo comparator | This arm will receive placebo. Receives: Drug: Placebo 1.5 ml, prefilled pen-injector for subcutaneous injection solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Ascertained at the end of 9 months
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline to 9 months
Change in Body Fat Percentage
Measured using bioelectrical impedance analysis
Measured: 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)
Measured: Assessed at end of 9 months
Receipt of Kidney Transplant
Confirmed by review of electronic health record (EHR)
Measured: Assessed at end of 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start23 Jul 2021
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
Why it stopped: low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CKDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Chang, Geisinger Clinic
- Investigators
- Alex R Chang, MD, MS, Principal investigator, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04741074
- Sponsor's protocol ID
- 2020-1050
- Other IDs
- Universal Trial Number
- Acronym
- RAISE-KT
- Status last verified
- Feb 2024
- First submitted
- 2 Feb 2021
- Last updated
- 9 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A RAndomized trIal Examining the Effect of Subcutaneous Semaglutide on Kidney Transplant Candidacy for Patients With Stage 4-5 CKD or Dialysis-dependent ESKD
- ClinicalTrials.gov ID
- NCT04741074
- Acronym / sponsor ID
- RAISE-KT / 2020-1050
- Keywords
- ckd, obesity, kidney transplant, transplant wait list, diabetic kidney disease, glp-1, semaglutide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low recruitment
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Study start
- 23 Jul 2021 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 5 Feb 2021 (actual)
- Results
- Posted 9 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Transplant policies regarding listing consider uncontrolled diabetes and severe obesity to be contraindications though there is great variability for exact BMI (35-45 kg/m2) and A1c (9-10%) thresholds for listing by center. Glucagon-lowering peptide-1 receptor agonists (GLP-1 RAs) offer great promise in this population as they have been shown to reduce weight, central adiposity, A1c, and risk of cardiovascular outcomes with similar effects in patients with and without CKD.
In this double-blind, placebo-controlled randomized controlled trial, the investigators will evaluate the effect of subcutaneous semaglutide 1.34 mg/ml (up to 1.0 mg per week) in combination with lifestyle counseling in patients with T2DM, overweight/obesity, and stage 4-5 CKD or dialysis-dependent ESKD on patients' eligibility for kidney transplantation in terms of diabetes control (A1c <9%) and obesity (BMI <35 kg/m2 or 35-40 kg/m2 with waist circumference <120 cm) at the end of 9 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Semaglutide | Active comparator | Drug: Semaglutide 2 mg/1.5 ml (1.34 mg/ml), prefilled pen-injector for subcutaneous injection solutionThis arm will receive semaglutide. |
| Placebo | Placebo comparator | Drug: Placebo 1.5 ml, prefilled pen-injector for subcutaneous injection solutionThis arm will receive placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (38 listed)
- - Age ≥ 18 years
- - BMI 25-45 kg/m2
- - T2DM
- - 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).
- - 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].
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semaglutide 2 mg/1.5 ml (1.34 mg/ml), prefilled pen-injector for subcutaneous injection solutionAlso: semaglutideDose 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. | Drug | Semaglutide |
| Placebo 1.5 ml, prefilled pen-injector for subcutaneous injection solutionAlso: placeboMatched 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. | Drug | Placebo |
Primary outcome
Kidney Transplant Eligibility
Time frame: Ascertained at the end of 9 months
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)
7 secondary outcomes
Change in Hemoglobin A1c (HgbA1c)
Time frame: From baseline to 9 months
Change in BMI
Time frame: From baseline to 9 months
Change in Waist Circumference
Time frame: From baseline to 9 months
Change in Waist-to-hip Ratio
Time frame: From baseline to 9 months
Change in Body Fat Percentage
Time frame: From baseline to 9 months
New Activation on the Transplant List
Time frame: Assessed at end of 9 months
Receipt of Kidney Transplant
Time frame: Assessed at end of 9 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alex R Chang, MD, MS principal investigator
Geisinger Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Semaglutide 2 mg/1.5 ml (1.34 mg/ml), prefilled pen-injector for subcutaneous injection solution in people with CKD and Diabetic Kidney Disease, run by Geisinger Clinic at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 38 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kidney Transplant Eligibility (time frame: Ascertained at the end of 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2024.