Clinical trial · Interventional
Effects of DPP4 Inhibitor on Cisplatin Induced Acute Kidney Injury
Effect of DPP4 Inhibitors on Cisplatin-induced Acute Kidney Injury
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Cisplatin is a potent chemotherapeutic agent, however, its nephrotoxicity manifested by acute kidney injury (AKI) often limits applicability. Dipeptidylpeptidase-4 (DPP4) inhibitors are well known to improve glucose intolerance by augmentation of endogenous glucagon like peptide (GLP-1) and glucose-dependent insulinotropic peptide (GIP). DPP4 inhibitor also has the potential anti-apoptotic and renoprotective effect in a mouse model of cisplatin-induced AKI. This is a single-center, randomized, double-blind, parallel-group, placebo-controlled, prospective study to investigate the renoprotective effect of DPP4 inhibitor on cisplatin-induced AKI. A total 182 patients, who are scheduled to treat with cisplatin, will be recruited and randomly assigned to either Gemigliptin or placebo groups. Subjects will take study drugs for 8 days starting from one day before cisplatin treatment. Serum creatinine (Cr) and estimated glomerular filtration rate (eGFR) will be measured at 7 days after cisplatin treatment.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Cisplatin Adverse Reaction | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Gemigliptin | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Experimental: Gemigliptin and Cisplatin
- description
- Gemigliptin 100mg daily in two divided doses for 8 days starting from one day before cisplatin-treatment
- interventionNames
- Drug: Gemigliptin
- Drug: Cisplatin
- type
- PLACEBO_COMPARATOR
- label
- Control arm
- description
- Placebo 100mg daily in two divided doses for 8 days starting from one day before cisplatin-treatment
- interventionNames
- Drug: Placebo
- Drug: Cisplatin
Primary outcomes (1)
- measure
- Incidence of acute kidney injury defined as any of the followings
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * age \> 18 years * cancer patients treated with intravenous cisplatin * written consent Exclusion Criteria: * Diabetes mellitus * Chronic kidney disease stage IV-V (eGFR \< 30ml/min/1.73m2) * History of transplantation * History of acute kidney injury before randomization * Use of other nephrotoxic agents such as non steroidal anti-inflammatory drugs, aminoglycosides, colistin, vancomycin * Receiving contrast media during last 72 hours * Liver disease (bilirubin \> 2 mg/dl, transaminase levels \>2.5 times the upper limit normal) * Active infection * Patients with high risks of dehydration owing to poor oral intake * High blood pressure (\> 180/110 mmHg despite antihypertensive medications) * Hypersensitivity to Gemigliptin or its excipients * Low compliance to Gemigliptin treatment
References
Publications (2)
- RESULTKatagiri D, Hamasaki Y, Doi K, Okamoto K, Negishi K, Nangaku M, Noiri E. Protection of glucagon-like peptide-1 in cisplatin-induced renal injury elucidates gut-kidney connection. J Am Soc Nephrol. 2013 Dec;24(12):2034-43. doi: 10.1681/ASN.2013020134. Epub 2013 Oct 3. PMID 24092928
- DERIVEDBaek SH, Kim SH, Kim JW, Kim YJ, Lee KW, Na KY. Effects of a DPP4 inhibitor on cisplatin-induced acute kidney injury: study protocol for a randomized controlled trial. Trials. 2015 May 29;16:239. doi: 10.1186/s13063-015-0772-4. PMID 26021829