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Renal ImpairmentPhase 1NCT02007941

Comparative Evaluation of Pharmacokinetics After CKD-501 Between Renal Impaired and Normal Renal Function Subjects

A Phase 1 study testing CKD-501 in people with Renal Impairment and Healthy, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.

Completed

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

Official record
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Trial summary

The purpose of this study is to assess between the renal impaired patients and normal renal function subjects comparetive evaluation to Pharmacokinetics after CKD-501 Future, When prescription CKD-501 to renal impaired patient, It will be guidelines to provide a basis of instructions. Read more about this study

Who is it for?
Ages 20 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Renal Impairment, Healthy
What is being tested?
CKD-501
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteSouth Korea
Study dates
Apr 2014to Apr 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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • All subjects:
  • Adult males or females, 20 - 65 years of age (inclusive);
  • Body mass index (BMI) range of approximately 18.5-29.9 kg/㎡ (inclusive);
  • Agreement with written informed consent
  • Agree to Medically acceptable method of contraception during clinical trials
  • Normal Renal Function subjects:
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  • Matched to renal impaired patients(ESRD) in the study by age (±7 years), sex and BMI
  • Medically healthy with clinically insignificant screening results (e.g., laboratory profiles, medical history, EKG, physical examination);
  • eGFR ≥ 90 mL/min/1.73mE2;
  • Renally impaired subjects:
  • Matched to renal impaired patients(ESRD) in the study by age (±7 years), sex and BMI
  • Subjects with mild renal impairment (eGFR 60-89 mL/min/1.73mE2) OR moderate renal impairment (eGFR 30-59 mL/min/1.73mE2) OR severe renal impairment (eGFR 15-29 mL/min/1.73mE2) OR dialysis end stage renal disease(ESRD)

Who cannot join

  • All subjects:
  • The subject's systolic blood pressure is outside the range of 100-180mmHg, or diastolic blood pressure is outside the range of 50-110mmHg
  • Repeatedly Screening ECG parameters (PR ≥ 210 mse,QRS ≥ 120 msec, QTcF ≥ 500 msec)
  • Repeatedly lab(AST >1.25xULN, ALT>1.25xULN ,Total bilirubin >1.5xULN)
  • A positive pre-study drug screen.(amphetamines, barbiturates, cocaine, opiates, cannabinoids, benzodiazepin)
  • Clinically significant allergic diseases or History of thiazolidinedione class's anaphylaxis reactions
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  • Can not stop to be taking caffeine (caffeine > 400mg/day), drinking(alcohol > 30 g/day) or severe heavy smoker(cigarette > 10 cigarettes/day) during clinical trials
  • Consumption of food which may affect study within 7 days prior to first dose of study medication or taking a dietary supplement now or continued.
  • Consumption of drug which may affect study within 7 days prior to first dose of study medication.
  • Previously donate whole blood within 60 days or component blood within 30 days prior to first dose of study medication.
  • blood transfusion within 30 days prior to first dose of study medication.
  • Subjects with participation in another clinical trial within 60 days prior to the study
  • An impossible one who participates in clinical trial by Principal investigator's decision
  • Normal Renal Function subjects:
  • Subjects with a history of chronic disease or an acute illness within 28 days of study medication administration
  • Subjects with a history of gastrointestinal disease effected study medication or surgery(except appendectomy, hernia surgery)
  • Current or chronic history of liver disease or ascites or hepatic encephalopathy
  • Renally impaired subjects:
  • Type I diabetes, Diabetic ketoacidosis, diabetic coma or a history of coma (controllable Type II diabetes including possible)
  • Uncontrollable hypertension or severe heart failure
  • require treatment with steroid or immunosuppressive drug
  • History of renal transplant or undergoing other dialysis method except hemodialysis
  • Needs treatment for acute disease, uncontrolled other disease or diabetic complications
  • Current or chronic history of liver disease or ascites or hepatic encephalopathy
  • Subjects with a history of chronic disease or an acute illness within 28 days of study medication administration
  • Subjects with a history of gastrointestinal disease effected study medication or surgery(except appendectomy, hernia surgery)

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • The Inje University Busan Paik Hospital

    Busan

Other trials in South Korea

About this study

Official title: An Open-label, Non-randomized, Parallel-group Design Clinical Trial for Comparative Evaluation of Pharmacokinetics After CKD-501 Between Patients With Renal Impairment and Control Subjects With Normal Renal Function

The purpose of this study is to assess between the renal impaired patients and normal renal function subjects comparetive evaluation to Pharmacokinetics after CKD-501 Future, When prescription CKD-501 to renal impaired patient, It will be guidelines to provide a basis of instructions.

Read the detailed description

A Phase 1, Non-randomized, Open, Parallel-Group Clinical trial

Being tested
CKD-501
Medical subject headings
Renal Insufficiency

What participants receive

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

  • CKD-501Drug

    Also called Lobeglitazone

    From day 1 to day 3, Once(Day1) CKD-501 0.5mg is administered .

Study groups in NCT02007941
Study groupRoleWhat they receive
End Stage Renal Disease(ESRD)ExperimentalCKD-501 will be administered to patients who have required dialysis and non-dialysis eGFR(estimate glomerular filtration rate ) is Less than 15. First, ESRD Patient and normal renal function Subjects are conducted. After the interim analysis, Determine whether early termination or renal impaired subject's progress
Receives: Drug: CKD-501
normal renal functionActive comparatorCKD-501 will be administered to normal renal function subject who have eGFR(estimate glomerular filtration rate ) of 90 or more. First, ESRD Patient and normal renal function Subjects are conducted. After the interim analysis, Determine whether early termination or renal impaired subject's progress
Receives: Drug: CKD-501
Mild renal impairmentExperimentalCKD-501 will be administered to patients who have eGFR(estimate glomerular filtration rate ) is 60 to 89 that.
Receives: Drug: CKD-501

What is being measured

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

  1. The pharmacokinetic( Cmax, AUCt ) of lobeglitazone(CKD-501) Between Renal Impaired patients and Normal Renal function subjects

    • Blood sampling timepoint : (Day 1) 0hr, 0.33hr, 0.66hr, 1hr, 1.5hr, 2hr, 3hr, 6hr, 12hr, 24hr (Day 2)36hr (Day3)48hr- total 12 timepoints per period
    • Additional Blood sampling for unbound fraction analysis : (Day 1) 1hr, 6hr, 12hr
    • Urine collection : (Day 1)0-6hr, 6-12hr, 12-24hr (Day 2) 24-36hr, 36-48hr

    Measured: 0-48 hrs

Secondary outcomes (1)

  1. The pharmacokinetic( Cmax, AUCt ) of main metabolites(M7) of CKD-501 Between Renal Impaired patients and Normal Renal function subjects

    • Blood sampling timepoint : (Day 1) 0hr, 0.33hr, 0.66hr, 1hr, 1.5hr, 2hr, 3hr, 6hr, 12hr, 24hr (Day 2)12hr (Day3)0hr- total 12 timepoints per period
    • Urine collection : (Day 1)0-6hr, 6-12hr, 12-24hr (Day 2) 24-36hr, 36-48hr

    Measured: 0-48 hrs

Timeline

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

  1. First posted11 Dec 2013 (estimated)
  2. Study startApr 2014
  3. Primary completionApr 2015
  4. Study completionApr 2015

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02007941
Sponsor's protocol ID
19RI113017
Status last verified
Dec 2016
First submitted
3 Dec 2013
Last updated
6 Dec 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CKD-501 in people with Renal Impairment and Healthy, run by Chong Kun Dang Pharmaceutical 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 12 inclusion and 26 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 6 Dec 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. 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?

The pharmacokinetic( Cmax, AUCt ) of lobeglitazone(CKD-501) Between Renal Impaired patients and Normal Renal function subjects (time frame: 0-48 hrs). 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 NCT02007941.

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 6 Dec 2016.

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