Chronic Renal FailurePhase 2NCT02378194
Change From Baseline to Chronic Kidney Disease Patient Before and After Administration Drug
A Phase 2 study testing HD-003 (800mg/day) and HD-003 (1600mg/day) in people with Chronic Renal Failure, run by Hyundai Pharmaceutical Co., LTD..
Trial summary
Chronic renal failure is a syndrome that renal function is decreased, and the patient number is increasing. In addition, patients on dialysis have also increased. Depending on the chronic renal failure aggravated, the deterioration of life caused by the conduct of dialysis patients is caused. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Chronic Renal Failure
- What is being tested?
- HD-003 (800mg/day) and HD-003 (1600mg/day)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Mar 2013
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient diagnosed with chronic renal failure which subjected to conservation therapy.
- Patient has 15~59mL/min/1.736m2 glomerular filtration rate.
- Serum creatinine(sCr) is in the range of 1.5~5.0mg/dL at the start of the test and until the start of the test from 52 weeks the serum creatinine is three times more than the number of measurements, and during the final test values of serum creatinine patients with advanced value rises 0.2mg/dL or higher than the first tests.
- From the start of the test until 52 weeks before the test, serum creatinine the slope of the straight line for the inverse of the value is less than the rare patient -0.0001
- Inpatient or outpatient
- Age: 20~75, gender: both
Who cannot join
- Patient who start treatment drug or diet that maybe inhibit progress of renal failure within 3 months of the study start
- Diabetic patients with unstable blood sugar regulation.
- Patient did not have blood pressure control
- Patient taking the combination of prohibited substances
- Dialysis patient
- Patient with gout
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- Patient who merged with a progressive muscular dystrophy, polymyositis, etc.
- Patients with symptoms of cerebral vascular disorders
- Women who are pregnant or breast-feeding
- Patient with infectious disease
- Patient with gastric ulcer
- Patients who has difficult diet, medication, etc.
- Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- Subjects with decision of nonparticipation through investigator's review due to laboratory test results or other excuse such as non-responding to request or instruction by investigator
About this study
Chronic renal failure is a syndrome that renal function is decreased, and the patient number is increasing. In addition, patients on dialysis have also increased. Depending on the chronic renal failure aggravated, the deterioration of life caused by the conduct of dialysis patients is caused. In addition, a problem in dialysis treatment is ongoing economic burden surface to increase the life of the patient and family. A solution to this problem is, or stops the progression of chronic renal failure prior to dialysis, it is necessary to delay. As a treatment for inhibiting the progression of chronic renal failure is present, along with diet and blood pressure-lowering drugs or a drug therapy used by kremezin. However, the effect is not enough, new drug development is required.
HD-003 is a novel compound, and found to inhibit the renal failure progression. It was found during the search active substance that appear when the inflammation in animals. The investigators confirmed that the substance is present in the urine of a person during the study, and later established a link between kidney disease hypotheses. When performing the test in animal model renal failure, chronic renal Through the non-clinical testing of the HD-003(general toxicity studies, reproductive, developmental toxicity test, mutagenicity test and antigen tests) showed that a very low toxicity. When going through the review of the safety and pharmacokinetic Phase 1 clinical study, it was confirmed a very satisfactory safety and tolerability. And pharmacokinetic results from the body's absorption in healthy subjects had been done well, a linear correlation was observed. Finally, it was confirmed that the most rapidly excreted into the urine.
This study is a Phase 2a clinical trials performed in patients with chronic renal failure in 3, 4 steps. The evaluation of changes in serum creatinine(sCr) in vivo indicator of renal failure according to the progress. Evaluating the inhibitory effect of HD-003 renal failure progression and dose setting, and to determine the safety.
- Conditions
- Chronic Renal Failure
- Being tested
- Placebo, HD-003 (800mg/day), HD-003 (1600mg/day)
- Keywords
- in stage 3 or 4 steps
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
24 weeks, once daily oral administration
HD-003 (800mg/day)Drug
24 weeks, once daily oral administration
HD-003 (1600mg/day)Drug
24 weeks, once daily oral administration
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | Not described Receives: Drug: Placebo |
| HD-003 (800mg/day) | Experimental | Not described Receives: Drug: HD-003 (800mg/day) |
| HD-003 (1600mg/day) | Experimental | Not described Receives: Drug: HD-003 (1600mg/day) |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum creatinine rate inverse number's change
Measured: up to 24 weeks
GFR measurements (confirmed by the method MDRD via the value of sCr)
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2015 (estimated)
- Study startJan 2010
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Renal FailureStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hyundai Pharmaceutical Co., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Choi, Principal investigator, Yonsei University Health System, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02378194
- Sponsor's protocol ID
- HD-003
- Status last verified
- Feb 2015
- First submitted
- 10 Feb 2015
- Last updated
- 16 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Change From Baseline to Chronic Kidney Disease Patient Before and After Administration Drug
- ClinicalTrials.gov ID
- NCT02378194
- Acronym / sponsor ID
- HD-003
- Conditions
- Chronic Renal Failure
- Keywords
- in stage 3 or 4 steps
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Hyundai Pharmaceutical Co., LTD.Industry (pharma, biotech, devices)
- Study start
- Jan 2010 (actual)
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 4 Mar 2015 (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.
Chronic renal failure is a syndrome that renal function is decreased, and the patient number is increasing. In addition, patients on dialysis have also increased. Depending on the chronic renal failure aggravated, the deterioration of life caused by the conduct of dialysis patients is caused. In addition, a problem in dialysis treatment is ongoing economic burden surface to increase the life of the patient and family. A solution to this problem is, or stops the progression of chronic renal failure prior to dialysis, it is necessary to delay. As a treatment for inhibiting the progression of chronic renal failure is present, along with diet and blood pressure-lowering drugs or a drug therapy used by kremezin. However, the effect is not enough, new drug development is required.
HD-003 is a novel compound, and found to inhibit the renal failure progression. It was found during the search active substance that appear when the inflammation in animals. The investigators confirmed that the substance is present in the urine of a person during the study, and later established a link between kidney disease hypotheses. When performing the test in animal model renal failure, chronic renal Through the non-clinical testing of the HD-003(general toxicity studies, reproductive, developmental toxicity test, mutagenicity test and antigen tests) showed that a very low toxicity. When going through the review of the safety and pharmacokinetic Phase 1 clinical study, it was confirmed a very satisfactory safety and tolerability. And pharmacokinetic results from the body's absorption in healthy subjects had been done well, a linear correlation was observed. Finally, it was confirmed that the most rapidly excreted into the urine.
This study is a Phase 2a clinical trials performed in patients with chronic renal failure in 3, 4 steps. The evaluation of changes in serum creatinine(sCr) in vivo indicator of renal failure according to the progress. Evaluating the inhibitory effect of HD-003 renal failure progression and dose setting, and to determine the safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Drug: Placebo |
| HD-003 (800mg/day) | Experimental | Drug: HD-003 (800mg/day) |
| HD-003 (1600mg/day) | Experimental | Drug: HD-003 (1600mg/day) |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient diagnosed with chronic renal failure which subjected to conservation therapy.
- Patient has 15~59mL/min/1.736m2 glomerular filtration rate.
- Serum creatinine(sCr) is in the range of 1.5~5.0mg/dL at the start of the test and until the start of the test from 52 weeks the serum creatinine is three times more than the number of measurements, and during the final test values of serum creatinine patients with advanced value rises 0.2mg/dL or higher than the first tests.
- From the start of the test until 52 weeks before the test, serum creatinine the slope of the straight line for the inverse of the value is less than the rare patient -0.0001
- Inpatient or outpatient
Key exclusion criteria (14 listed)
- Patient who start treatment drug or diet that maybe inhibit progress of renal failure within 3 months of the study start
- Diabetic patients with unstable blood sugar regulation.
- Patient did not have blood pressure control
- Patient taking the combination of prohibited substances
- Dialysis patient
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 |
|---|---|---|
| Placebo24 weeks, once daily oral administration | Drug | Placebo group |
| HD-003 (800mg/day)24 weeks, once daily oral administration | Drug | HD-003 (800mg/day) |
| HD-003 (1600mg/day)24 weeks, once daily oral administration | Drug | HD-003 (1600mg/day) |
Primary outcome
serum creatinine rate inverse number's change
Time frame: up to 24 weeks
GFR measurements (confirmed by the method MDRD via the value of sCr)
Time frame: up to 24 weeks
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 16 Jun 2017.
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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.
Choi principal investigator
Yonsei University Health System, Severance Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HD-003 (800mg/day) and HD-003 (1600mg/day) in people with Chronic Renal Failure, run by Hyundai Pharmaceutical Co., LTD..
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 6 inclusion and 14 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 16 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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 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.
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?
serum creatinine rate inverse number's change (time frame: up to 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jun 2017.