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Effect of Subcutaneous Semaglutide on Kidney Transplant Candidacy
Phase 3 trial testing Semaglutide 2 mg/1.5 ml (1.34 mg/ml), prefilled pen-injector for subcutaneous injection solution in CKD in 15 participants. Terminated before completion.
| Lead sponsor | Geisinger Clinic |
|---|---|
| Phase | Phase 3 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 15 |
| Start date | 23 July 2021 |
| Primary completion | 31 January 2023 |
| Estimated completion | 31 January 2023 |
| Sites | 2 locations across United States |
Geisinger Clinic
18 and older, any sex, with CKD or Diabetic Kidney Disease. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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)
| Group | Value | 95% CI |
|---|---|---|
| Semaglutide | 3 | |
| Placebo | 2 |
HgbA1c will be collected using routine procedures and measured on the same day at the central Geisinger laboratory by Turbidimetric inhibition immunoassay.
| Group | Value | 95% CI |
|---|---|---|
| Semaglutide | -1.10 | ± 1.03 |
| Placebo | 0.33 | ± 0.78 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Semaglutide | -2.55 | ± 4.25 |
| Placebo | -.07 | ± 2.70 |
Waist circumference will be measured at each study visit to the nearest 0.1 cm using a Gulick II tape measure.
| Group | Value | 95% CI |
|---|---|---|
| Semaglutide | -0.52 | ± 14.38 |
| Placebo | 3.91 | ± 6.32 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Semaglutide | -.00 | ± 0.11 |
| Placebo | 0.03 | ± 0.05 |
Measured using bioelectrical impedance analysis
| Group | Value | 95% CI |
|---|---|---|
| Semaglutide | -2.70 | ± 1.93 |
| Placebo | 0.13 | ± 3.98 |
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)
| Group | Value | 95% CI |
|---|---|---|
| Semaglutide | 3 | |
| Placebo | 0 |
Confirmed by review of electronic health record (EHR)
| Group | Value | 95% CI |
|---|---|---|
| Semaglutide | 0 | |
| Placebo | 0 |
Collected at a Geisinger lab using routine procedures and measured on the same day at the central Geisinger laboratory by spectrophotometry.
| Group | Value | 95% CI |
|---|---|---|
| Semaglutide | -6.20 | ± 17.37 |
| Placebo | -6.17 | ± 53.63 |
Time frame: 9 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Semaglutide | Placebo |
|---|---|---|---|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | — | — |
| Syncope | Cardiac disorders | — | — |
| Uremia | Renal and urinary disorders | — | — |
| Hypertensive urgency | Cardiac disorders | — | — |
| Bacteremia | Infections and infestations | — | — |
| Appendicitis | Gastrointestinal disorders | — | — |
| Reaction | System | Semaglutide | Placebo |
|---|---|---|---|
| Hypoglycemia events | Endocrine disorders | — | — |
| Gastrointestinal disorders | Gastrointestinal disorders | — | — |
| Anemia or bleeding disorder | Blood and lymphatic system disorders | — | — |
| shortness of breath | Respiratory, thoracic and mediastinal disorders | — | — |
| Foot ulcer | Skin and subcutaneous tissue disorders | — | — |
| Hypertension | Cardiac disorders | — | — |
| Gallbladder disorders | Hepatobiliary disorders | — | — |
| Neoplasms | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Hepatic events | Hepatobiliary disorders | — | — |
| Allergic reactions | Immune system disorders | — | — |
| Injection-site reactions | Skin and subcutaneous tissue disorders | — | — |
| Acute pancreatitis | Gastrointestinal disorders | — | — |
Most-reported serious reactions: Pneumonia, Syncope, Uremia, Hypertensive urgency, Bacteremia, Appendicitis.
Data from ClinicalTrials.gov NCT04741074 adverse events section.
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.
4 peer-reviewed publications reference this trial (live from Europe PMC):
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing