Clinical trial NCT02250872: Effects of DPP4 Inhibitor on Cisplatin Induced Acute Kidney Injury
Official title: Effect of DPP4 Inhibitors on Cisplatin-induced Acute Kidney Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Cancer
Cisplatin Adverse Reaction
Keywords: Cisplatin
Nephrotoxicity
Gemigliptin
DPP4 inhibitor
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
Collaborators: name: LG Life Sciences
First posted: 2014-09-26
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This study will investigate possible renoprotective effects of DPP4 inhibitor on cisplatin induced acute kidney injury.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of acute kidney injury defined as any of the followings
timeFrame: up to 7 days
Secondary outcomes:
measure: delta Cr
timeFrame: Time Frame: up to 7 days
measure: delta eGFR
timeFrame: up to 7 days
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Ki Young Na
role: PRINCIPAL_INVESTIGATOR
References:
citation: Katagiri 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.
citation: Baek 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.