Renal ImpairmentPhase 1NCT02214693

PK//PD/Tolerability Study of DA-1229(Evogliptin) in Renal Impaired Patients

A Phase 1 study testing DA-1229 in people with Renal Impairment, run by Dong-A ST Co., Ltd. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a clinical study to investigate the pharmacokinetics/pharmacodynamics and tolerability of DA-1229(Evogliptin) tabletin renal impaired patients. Read more about this study

Who is it for?: Ages 20 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Renal Impairment
What is being tested?: DA-1229
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteSouth Korea
Study dates: Jul 2014to Mar 2015
Phase: Phase 1
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 20 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Age between 20 and 70
Weights between 50 and 90kg(Female : 40 and 90kg)
Volunteer who totally understands the progress of this clinical trials, makes decision by his free will, and signed a consent form to follow the progress
Stable results of estimated GFR in 4 months recently

Who cannot join

Volunteer who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, Neurology, immunology, pulmonary, endocrine, hematooncology, cardiology, mental disorder)
Volunteer who had drug(DPP-4 inhibitor) hypersensitivity reaction
Volunteer who already participated in other trials in 2 months
Volunteer who had whole blood donation in 2 months, or component blood donation in 1 months or transfusion

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Clinical Trial Center, Seoul National University Hospital
Seoul

Other trials in South Korea

About this study

Official title: A Clinical Study to Investigate the Pharmacokinetics/Pharmacodynamics and Tolerability of DA-1229(Evogliptin) Tablet in Renal Impaired Patients

This is a clinical study to investigate the pharmacokinetics/pharmacodynamics and tolerability of DA-1229(Evogliptin) tabletin renal impaired patients.

Conditions: Renal Impairment
Being tested: DA-1229
Keywords: patients
Medical subject headings: Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DA-1229Drug
Also called Evogliptin

Study groups in NCT02214693
Study group	Role	What they receive
Group 1(Severe decrease in GFR)	Experimental	Severe decrease in GFR Receives: Drug: DA-1229
Group 2(Moderate decrease in GFR)	Experimental	Moderate decrease in GFR Receives: Drug: DA-1229
Group 3(Mild decrease in GFR)	Experimental	Mild decrease in GFR Receives: Drug: DA-1229
Group 4(Normal GFR)	Experimental	Normal GFR Receives: Drug: DA-1229

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under Curve(AUC) last
Measured: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 60, 72, 96, 120h post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2014Mar 2015

First posted12 Aug 2014 (estimated)
Study startJul 2014
Primary completionMar 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Renal ImpairmentStudies of the same condition, open and under way.
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 1
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02214693
Sponsor's protocol ID: DA1229_RI_I
Status last verified: Aug 2015
First submitted: 11 Aug 2014
Last updated: 27 Aug 2015
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
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Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
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NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
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Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
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Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
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All Renal Impairment trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Clinical Study to Investigate the Pharmacokinetics/Pharmacodynamics and Tolerability of DA-1229(Evogliptin) Tablet in Renal Impaired Patients
ClinicalTrials.gov ID: NCT02214693
Acronym / sponsor ID: DA1229_RI_I
Conditions: Renal Impairment
Keywords: patients
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
Study start: Jul 2014
Primary completion: Mar 2015 (actual)
First posted: 12 Aug 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.

This is a clinical study to investigate the pharmacokinetics/pharmacodynamics and tolerability of DA-1229(Evogliptin) tabletin renal impaired patients.

Study design

Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Group 1(Severe decrease in GFR)	Experimental	Drug: DA-1229Severe decrease in GFR
Group 2(Moderate decrease in GFR)	Experimental	Drug: DA-1229Moderate decrease in GFR
Group 3(Mild decrease in GFR)	Experimental	Drug: DA-1229Mild decrease in GFR
Group 4(Normal GFR)	Experimental	Drug: DA-1229Normal GFR

Who may qualify

Ages: 20 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Age between 20 and 70
Weights between 50 and 90kg(Female : 40 and 90kg)
Volunteer who totally understands the progress of this clinical trials, makes decision by his free will, and signed a consent form to follow the progress
Stable results of estimated GFR in 4 months recently

Key exclusion criteria (4 listed)

Volunteer who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, Neurology, immunology, pulmonary, endocrine, hematooncology, cardiology, mental disorder)
Volunteer who had drug(DPP-4 inhibitor) hypersensitivity reaction
Volunteer who already participated in other trials in 2 months
Volunteer who had whole blood donation in 2 months, or component blood donation in 1 months or transfusion

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
DA-1229Also: Evogliptin	Drug	Group 1(Severe decrease in GFR), Group 2(Moderate decrease in GFR), Group 3(Mild decrease in GFR), Group 4(Normal GFR)

Primary outcome

Area Under Curve(AUC) last
Time frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 60, 72, 96, 120h post-dose

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2015.

Related trials for Renal Impairment

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DA-1229 in people with Renal Impairment, run by Dong-A ST Co., Ltd. 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 27 Aug 2015. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under Curve(AUC) last (time frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 60, 72, 96, 120h post-dose). 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 NCT02214693.

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 27 Aug 2015.