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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
Show all 12Show fewer
  • 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

82 31 787 7030

South Korea1 site, 1 recruiting

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 463-707

    Hyunjin Cho, 82 31 787 7030

    Ki Young Na, MD PhD

    Recruiting

Other trials in South Korea

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.

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 groups in NCT02250872
Study groupRoleWhat they receive
Experimental: Gemigliptin and CisplatinActive comparatorGemigliptin 100mg daily in two divided doses for 8 days starting from one day before cisplatin-treatment
Receives: Drug: Gemigliptin; Drug: Cisplatin
Control armPlacebo comparatorPlacebo 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.

  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.

    Measured: up to 7 days

Secondary outcomes (2)

  1. delta Cr

    Change of serum creatinine from baseline to 7 days after cisplatin treatment.

    Measured: Time Frame: up to 7 days

  2. 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.

  1. First posted26 Sep 2014 (estimated)
  2. Study startDec 2014
  3. Primary completionFeb 2018 (estimated)
  4. Study completionJun 2018 (estimated)

Resources

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)
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 24092928

  • 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.

    PubMed 26021829

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.

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