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| Name | Class |
|---|---|
| LG Life Sciences | INDUSTRY |
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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.
This study will investigate possible renoprotective effects of DPP4 inhibitor on cisplatin induced acute kidney injury.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Gemigliptin and Cisplatin | Active Comparator | Gemigliptin 100mg daily in two divided doses for 8 days starting from one day before cisplatin-treatment |
|
| Control arm | Placebo Comparator | Placebo 100mg daily in two divided doses for 8 days starting from one day before cisplatin-treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemigliptin | Drug | Gemigliptin 100mg in 2 divided doses plus cisplatin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of acute kidney injury defined as any of the followings |
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 |
| Measure | Description | Time Frame |
|---|---|---|
| delta Cr | Change of serum creatinine from baseline to 7 days after cisplatin treatment. | Time Frame: up to 7 days |
| delta eGFR | Change of glomerular filtration rate calculated by the Chronic Kidney Disease Epidemiology Collaboration equations (CKD EPI) from baseline to 7 days after cisplatin treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ki Young Na | Contact | 82 31 787 7030 |
| Name | Affiliation | Role |
|---|---|---|
| Ki Young Na | Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Recruiting | Seongnam-si | Gyeonggi-do | 463-707 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24092928 | Result | 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. | |
| 26021829 | Derived | 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. |
| Label | URL |
|---|---|
| cisplatin | View source |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C534891 | LC15-0444 |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| Placebo | Drug | 100mg in 2 divided doses plus cisplatin |
|
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| Cisplatin | Drug | All patients will receive intravenous cisplatin |
|
| up to 7 days |
| gemigliptin | View source |
| U.S. FDA Resources | View source |