CancerPhase 2/3NCT02250872
Effects of DPP4 Inhibitor on Cisplatin Induced Acute Kidney Injury
A Phase 2/3 study testing Gemigliptin and Cisplatin in people with Cancer and Cisplatin Adverse Reaction, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cancer, Cisplatin Adverse Reaction
- What is being tested?
- Gemigliptin and Cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 182 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2014to Jun 2018
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 18 years
- cancer patients treated with intravenous cisplatin
- written consent
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Ki Young Na contact
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
Hyunjin Cho, 82 31 787 7030
Ki Young Na, MD PhD
About this study
Official title: Effect of DPP4 Inhibitors on Cisplatin-induced Acute Kidney Injury
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.
Read the detailed description
This study will investigate possible renoprotective effects of DPP4 inhibitor on cisplatin induced acute kidney injury.
- Conditions
- Cancer, Cisplatin Adverse Reaction
- Being tested
- Gemigliptin, Placebo, Cisplatin
- Keywords
- Cisplatin, Nephrotoxicity, Gemigliptin, DPP4 inhibitor
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemigliptinDrug
Also called Zemiglo
Gemigliptin 100mg in 2 divided doses plus cisplatin
PlaceboDrug
Also called Identical inert tablet to mimic gemigliptin (50mg)
100mg in 2 divided doses plus cisplatin
CisplatinDrug
All patients will receive intravenous cisplatin
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Gemigliptin and Cisplatin | Active comparator | Gemigliptin 100mg daily in two divided doses for 8 days starting from one day before cisplatin-treatment Receives: Drug: Gemigliptin; Drug: Cisplatin |
| Control arm | Placebo comparator | Placebo 100mg daily in two divided doses for 8 days starting from one day before cisplatin-treatment Receives: Drug: Placebo; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 7 days
Secondary outcomes (2)
delta Cr
Change of serum creatinine from baseline to 7 days after cisplatin treatment.
Measured: 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.
Measured: up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2014 (estimated)
- Study startDec 2014
- Primary completionFeb 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- LG Life Sciences
- Responsible party
- Principal investigator, Ki Young Na, Seoul National University Bundang Hospital
- Investigators
- Ki Young Na, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02250872
- Sponsor's protocol ID
- B1408264002
- Status last verified
- Apr 2016
- First submitted
- 24 Sep 2014
- Last updated
- 20 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 24092928Baek 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.
PubMed 26021829
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of DPP4 Inhibitors on Cisplatin-induced Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT02250872
- Acronym / sponsor ID
- B1408264002
- Conditions
- Cancer, Cisplatin Adverse Reaction
- Keywords
- Cisplatin, Nephrotoxicity, Gemigliptin, DPP4 inhibitor
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Collaborators
- LG Life Sciences
- Study start
- Dec 2014
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 26 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Gemigliptin and Cisplatin | Active comparator | Drug: Gemigliptin, Drug: CisplatinGemigliptin 100mg daily in two divided doses for 8 days starting from one day before cisplatin-treatment |
| Control arm | Placebo comparator | Drug: Placebo, Drug: CisplatinPlacebo 100mg daily in two divided doses for 8 days starting from one day before cisplatin-treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age > 18 years
- cancer patients treated with intravenous cisplatin
- written consent
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GemigliptinAlso: ZemigloGemigliptin 100mg in 2 divided doses plus cisplatin | Drug | Experimental: Gemigliptin and Cisplatin |
| PlaceboAlso: Identical inert tablet to mimic gemigliptin (50mg)100mg in 2 divided doses plus cisplatin | Drug | Control arm |
| CisplatinAll patients will receive intravenous cisplatin | Drug | Control arm, Experimental: Gemigliptin and Cisplatin |
Primary outcome
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.
2 secondary outcomes
delta Cr
Time frame: Time Frame: up to 7 days
delta eGFR
Time frame: up to 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2016.
- Results publication: PubMed 24092928Katagiri 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.
- Derived from this study: PubMed 26021829Baek 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.
- cisplatinLink provided by the sponsor.
- gemigliptinLink provided by the sponsor.
- U.S. FDA ResourcesLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ki Young Na contact
Ki Young Na principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Gemigliptin and Cisplatin in people with Cancer and Cisplatin Adverse Reaction, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ki Young Na (82 31 787 7030), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of acute kidney injury defined as any of the followings (time frame: up to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02250872, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2016.