Diabetic NephropathyPhase 2NCT01935167
To Determine the Efficacy and Safety of DW1029M on Microalbuminuria in Patients With Diabetic Nephropathy
A Phase 2 study testing DW1029M 600mg and DW1029M 1200mg in people with Diabetic Nephropathy, run by Dong Wha Pharmaceutical Co. Ltd. at 1 site in South Korea.
Trial summary
Phase 2 clinical study to evaluate of the efficacy and safety of DW1029M on microalbuminuria in Patients With Diabetic Nephropathy Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Diabetic Nephropathy
- What is being tested?
- DW1029M 600mg and DW1029M 1200mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 158 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2013to Feb 2015
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has confirmed diabetic mellitus prior to 6years
- Has confirmed microalbuminuria 30 ~ 299㎍/㎎creatinine prior to 5months one time and microalbuminuria 30 ~ 299㎍/㎎creatinine during screening period
- Blood Pressure(BP) ≤ 150 / 90 mmHg
- estimated glomerular filtration rate(eGFR) ≥ 30 ml/min/1.73m2
- Hemoglobin A1c(HbA1c) ≤ 9%
- Low density lipoprotein(LDL-C) ≤ 130mg/dl
Who cannot join
- kidney or liver disease as follows i.Serum Creatinine > 2.0mg/dl ii.Alanine Aminotransferase(ALT) or Aspartate Aminotransferase(AST) > 2 x Upper Limit Normal(ULN) iii.Total Bilirubin > 2 x ULN
- Organic gastrointestinal disorder or Chronic gastroenterologic disorders prior to 6 months as follows [NOTE] Active Crohn's disease, Active ulcerative colitis, Chronic peptic ulcer disease, etc.
- cardiovascular disease prior to 3 months as follows [NOTE] Unstable angina pectoris, Myocardial infarction, Coronary artery bypass surgery, Percutaneous Transluminal Coronary Angioplasty, transient ischemic attack, cerebrovascular accident etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase Ⅱ, Prospective, 24 Weeks, Double-blind, Placebo-controlled, Randomized, Multi-center Clinical Trial for the Evaluation of the Efficacy and Safety of DW1029M on Microalbuminuria in Patients With Diabetic Nephropathy
Phase 2 clinical study to evaluate of the efficacy and safety of DW1029M on microalbuminuria in Patients With Diabetic Nephropathy
Read the detailed description
A Phase Ⅱ, prospective, 24 weeks, double-blind, placebo-controlled, randomized, multi-center clinical trial for the evaluation of the efficacy and safety of DW1029M on microalbuminuria in Patients With Diabetic Nephropathy
- Conditions
- Diabetic Nephropathy
- Being tested
- DW1029M 600mg, DW1029M 1200mg, Placebo
- Keywords
- Microalbuminuria
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DW1029M 600mgDrug
Also called DW1029M 150mg 2 tablets
DW1029M 150mg 2 tablets b.i.d
DW1029M 1200mgDrug
Also called DW1029M 300mg 4 tablets
DW1029M 300mg 2 tablets b.i.d
PlaceboDrug
Placebo 2 tablets b.i.d.
| Study group | Role | What they receive |
|---|---|---|
| A Group | Experimental | DW1029M 600mg for 24 weeks Receives: Drug: DW1029M 600mg |
| B Group | Experimental | DW1029M 1200mg for 24 weeks Receives: Drug: DW1029M 1200mg |
| C Group | Placebo comparator | Placebo for 24 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
log ACR
logarithm of the Albumin Creatinine Ratio(ACR) after 24 weeks
Measured: 24 weeks after 1st administration
Secondary outcomes (5)
Log UAE
Urinary Albumin Excretion(UAE) after 12 and 24 weeks
Measured: 24 weeks after 1st administration
eGFR
estimated Glomerular Filtration Rate(eGFR) after 12 and 24 weeks
Measured: 12 and 24 weeks after 1st administration
log ACR
logarithm of the Albumin Creatinine Ratio(ACR) after 12 weeks
Measured: 12 weeks after 1st administration
SCC
Serum Creatinine Concentration(SCC) after 12 and 24 weeks
Measured: 12 and 24 weeks after 1st administration
Cystatin C
Cystatin C after 12 and 24 weeks
Measured: 12 and 24 weeks after 1st administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2013 (estimated)
- Study startOct 2013
- Primary completionAug 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NephropathyStudies 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
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong Wha Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MoonKyu Lee, Professor, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01935167
- Sponsor's protocol ID
- DW1029M
- Status last verified
- Feb 2017
- First submitted
- 30 Aug 2013
- Last updated
- 17 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅱ, Prospective, 24 Weeks, Double-blind, Placebo-controlled, Randomized, Multi-center Clinical Trial for the Evaluation of the Efficacy and Safety of DW1029M on Microalbuminuria in Patients With Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT01935167
- Acronym / sponsor ID
- DW1029M
- Conditions
- Diabetic Nephropathy
- Keywords
- Microalbuminuria
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Dong Wha Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 4 Sep 2013 (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.
Phase 2 clinical study to evaluate of the efficacy and safety of DW1029M on microalbuminuria in Patients With Diabetic Nephropathy
Detailed description
A Phase Ⅱ, prospective, 24 weeks, double-blind, placebo-controlled, randomized, multi-center clinical trial for the evaluation of the efficacy and safety of DW1029M on microalbuminuria in Patients With Diabetic Nephropathy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A Group | Experimental | Drug: DW1029M 600mgDW1029M 600mg for 24 weeks |
| B Group | Experimental | Drug: DW1029M 1200mgDW1029M 1200mg for 24 weeks |
| C Group | Placebo comparator | Drug: PlaceboPlacebo for 24 weeks |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Has confirmed diabetic mellitus prior to 6years
- Has confirmed microalbuminuria 30 ~ 299㎍/㎎creatinine prior to 5months one time and microalbuminuria 30 ~ 299㎍/㎎creatinine during screening period
- Blood Pressure(BP) ≤ 150 / 90 mmHg
- estimated glomerular filtration rate(eGFR) ≥ 30 ml/min/1.73m2
- Hemoglobin A1c(HbA1c) ≤ 9%
Key exclusion criteria (3 listed)
- kidney or liver disease as follows i.Serum Creatinine > 2.0mg/dl ii.Alanine Aminotransferase(ALT) or Aspartate Aminotransferase(AST) > 2 x Upper Limit Normal(ULN) iii.Total Bilirubin > 2 x ULN
- Organic gastrointestinal disorder or Chronic gastroenterologic disorders prior to 6 months as follows [NOTE] Active Crohn's disease, Active ulcerative colitis, Chronic peptic ulcer disease, etc.
- cardiovascular disease prior to 3 months as follows [NOTE] Unstable angina pectoris, Myocardial infarction, Coronary artery bypass surgery, Percutaneous Transluminal Coronary Angioplasty, transient ischemic attack, cerebrovascular accident etc.
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 |
|---|---|---|
| DW1029M 600mgAlso: DW1029M 150mg 2 tabletsDW1029M 150mg 2 tablets b.i.d | Drug | A Group |
| DW1029M 1200mgAlso: DW1029M 300mg 4 tabletsDW1029M 300mg 2 tablets b.i.d | Drug | B Group |
| PlaceboPlacebo 2 tablets b.i.d. | Drug | C Group |
Primary outcome
log ACR
Time frame: 24 weeks after 1st administration
logarithm of the Albumin Creatinine Ratio(ACR) after 24 weeks
5 secondary outcomes
Log UAE
Time frame: 24 weeks after 1st administration
eGFR
Time frame: 12 and 24 weeks after 1st administration
log ACR
Time frame: 12 weeks after 1st administration
SCC
Time frame: 12 and 24 weeks after 1st administration
Cystatin C
Time frame: 12 and 24 weeks after 1st administration
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 17 Feb 2017.
- Individual participant dataSharing planned: No
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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.
MoonKyu Lee, Professor principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DW1029M 600mg and DW1029M 1200mg in people with Diabetic Nephropathy, run by Dong Wha Pharmaceutical 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 6 inclusion and 3 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 17 Feb 2017. 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 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?
log ACR (time frame: 24 weeks after 1st administration). 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 17 Feb 2017.