Effects of DPP4 Inhibitor on Cisplatin Induced Acute Kidney Injury
Effect of DPP4 Inhibitors on Cisplatin-induced Acute Kidney Injury
1 other identifier
interventional
182
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 cancer
Started Dec 2014
Typical duration for phase_2 cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 24, 2014
CompletedFirst Posted
Study publicly available on registry
September 26, 2014
CompletedStudy Start
First participant enrolled
December 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedApril 20, 2016
April 1, 2016
3.2 years
September 24, 2014
April 18, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of acute kidney injury defined as any of the followings
* 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.
up to 7 days
Secondary Outcomes (2)
delta Cr
Time Frame: up to 7 days
delta eGFR
up to 7 days
Study Arms (2)
Experimental: Gemigliptin and Cisplatin
ACTIVE COMPARATORGemigliptin 100mg daily in two divided doses for 8 days starting from one day before cisplatin-treatment
Control arm
PLACEBO COMPARATORPlacebo 100mg daily in two divided doses for 8 days starting from one day before cisplatin-treatment
Interventions
Gemigliptin 100mg in 2 divided doses plus cisplatin
100mg in 2 divided doses plus cisplatin
All patients will receive intravenous cisplatin
Eligibility Criteria
You may qualify if:
- age \> 18 years
- cancer patients treated with intravenous cisplatin
- written consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seoul National University Bundang Hospitallead
- LG Life Sciencescollaborator
Study Sites (1)
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707, South Korea
Related Publications (2)
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.
PMID: 24092928RESULTBaek 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: 26021829DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ki Young Na
Seoul National University Bundang Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 24, 2014
First Posted
September 26, 2014
Study Start
December 1, 2014
Primary Completion
February 1, 2018
Study Completion
June 1, 2018
Last Updated
April 20, 2016
Record last verified: 2016-04