NCT02250872

Effect of DPP4 Inhibitors on Cisplatin-induced Acute Kidney Injury

Status unknown Phase 2/Phase 3 Last updated 18 April 2016

What this trial tests

Phase 2/Phase 3 trial testing Gemigliptin in Cancer in 182 participants. Status unknown.

Timeline

1 December 2014

Primary endpoint
1 February 2018

1 June 2018

Quick facts

Lead sponsor	Seoul National University Bundang Hospital
Phase	Phase 2/Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	182
Start date	1 December 2014
Primary completion	1 February 2018
Estimated completion	1 June 2018
Sites	1 location across South Korea

Drugs / interventions tested

• Gemigliptin (GEMIGLIPTIN) — full drug profile →
• Placebo
• Cisplatin (cisplatin) — full drug profile →

Conditions studied

• Cancer — all drugs for Cancer →
• Cisplatin Adverse Reaction — all drugs for Cisplatin Adverse Reaction →

Sponsor

Seoul National University Bundang Hospital

Who can join

Adults 18 to 70, any sex, with Cancer or Cisplatin Adverse Reaction. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Incidence of acute kidney injury defined as any of the followings
  Time frame: up to 7 days
  * Increase in sCr by ≥ 0.3 mg/dl * Increase in sCr to ≥ 1.5 times baseline * Decrease in eGFR to ≥ 25% All subjects receive Gemigliptin or placebo at a total dose of 100mg (50mg twice a day) for 8 consecutive days, serum creatinine will be measured.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Mechanisms of Cisplatin-Induced Acute Kidney Injury: Pathological Mechanisms, Pharmacological Interventions, and Genetic Mitigations.
   McSweeney KR, Gadanec LK, Qaradakhi T, Ali BA, et al · · 2021 · cited 241× · PMID 33805488 · DOI 10.3390/cancers13071572
2. Novel Therapies for Acute Kidney Injury.
   Chen H, Busse LW. · · 2017 · cited 43× · PMID 29270486 · DOI 10.1016/j.ekir.2017.06.020
3. Effects of a DPP4 inhibitor on cisplatin-induced acute kidney injury: study protocol for a randomized controlled trial.
   Baek SH, Kim SH, Kim JW, Kim YJ, et al · · 2015 · cited 20× · PMID 26021829 · DOI 10.1186/s13063-015-0772-4
4. Nephrotoxicity in cancer treatment: An update.
   Chen C, Xie D, Gewirtz DA, Li N. · · 2022 · cited 18× · PMID 35779877 · DOI 10.1016/bs.acr.2022.03.005