Chronic Kidney DiseasePhase 4NCT00858299
The Change of Urinary Angiotensinogen Excretion After Valsartan Treatment in Patients With Persistent Proteinuria
A Phase 4 study testing valsartan in people with Chronic Kidney Disease and Proteinuria, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
This study is a multicenter, prospective, interventional study. It does not have a control group. All participants will receive 160 mg valsartan for 8 weeks. Among them, the patients with persistent proteinuria (defined as proteinuria more than 1 g/g after 8 weeks treatment of valsartan) will receive 320 mg valsartan… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Kidney Disease, Proteinuria
- What is being tested?
- valsartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2009to Dec 2011
- Phase
- Phase 4
- 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
- Chronic kidney disease patients with
- proteinuria of 1 - 10 g/day,
- stable and controlled blood pressure (100/60 mmHg - 160/100 mmHg),
- stable renal function with GFR ≥ 30 mL/min/ m2,
- diabetes or non-diabetes
Who cannot join
- Uncontrolled diabetes (defined as HbA1c > 9.0%)
- Immunosuppressive treatment within 6 months
- Intractable edema
- Hyperkalemia (>5.5 mEq/L) or Hypokalemia (< 3.5 mEq/L)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Division of Nephrology, Samsung Medical Center
Seoul, Seoul, 135-710
Yoon-Goo Kim, Professor
About this study
Official title: The Change of Urinary Angiotensinogen Excretion After Valsartan Treatment in Chronic Kidney Diseases Patients With Persistent Proteinuria
This study is a multicenter, prospective, interventional study. It does not have a control group. All participants will receive 160 mg valsartan for 8 weeks. Among them, the patients with persistent proteinuria (defined as proteinuria more than 1 g/g after 8 weeks treatment of valsartan) will receive 320 mg valsartan for further 16 weeks. Participants who did not receive any ACEI or ARB previously will have a titration period for 4 weeks (80 mg for 4 weeks, 160 mg for 4 weeks, and then 320 mg for 16 weeks).
The investigators will evaluate the change of urinary angiotensinogen excretion between at baseline, at 8 weeks, and 24 weeks.
- Conditions
- Chronic Kidney Disease, Proteinuria
- Being tested
- valsartan
- Keywords
- proteinuria, chronic kidney disease, renin-angiotensin system, angiotensinogen
- Medical subject headings
- Renal Insufficiency, Chronic, Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
valsartanDrug
160 mg oral once in a day for initial 8 weeks and 320 mg, oral, once in a day for subsequent 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| valsartan | Experimental | Not described Receives: Drug: valsartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percent change of urinary angiotensinogen excretion between at baseline and at 24 weeks after valsartan treatment.
Measured: 4 weeks of screening periods + 24 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Yoon-Goo Kim, Professor, Principal investigator, Division of Nephrology, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00858299
- Sponsor's protocol ID
- 2008-07-089
- Status last verified
- Mar 2009
- First submitted
- 5 Mar 2009
- Last updated
- 9 Mar 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Change of Urinary Angiotensinogen Excretion After Valsartan Treatment in Chronic Kidney Diseases Patients With Persistent Proteinuria
- ClinicalTrials.gov ID
- NCT00858299
- Acronym / sponsor ID
- 2008-07-089
- Conditions
- Chronic Kidney Disease, Proteinuria
- Keywords
- proteinuria, chronic kidney disease, renin-angiotensin system, angiotensinogen
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 9 Mar 2009 (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 study is a multicenter, prospective, interventional study. It does not have a control group. All participants will receive 160 mg valsartan for 8 weeks. Among them, the patients with persistent proteinuria (defined as proteinuria more than 1 g/g after 8 weeks treatment of valsartan) will receive 320 mg valsartan for further 16 weeks. Participants who did not receive any ACEI or ARB previously will have a titration period for 4 weeks (80 mg for 4 weeks, 160 mg for 4 weeks, and then 320 mg for 16 weeks).
The investigators will evaluate the change of urinary angiotensinogen excretion between at baseline, at 8 weeks, and 24 weeks.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| valsartan | Experimental | Drug: valsartan |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chronic kidney disease patients with
Key exclusion criteria (4 listed)
- Uncontrolled diabetes (defined as HbA1c > 9.0%)
- Immunosuppressive treatment within 6 months
- Intractable edema
- Hyperkalemia (>5.5 mEq/L) or Hypokalemia (< 3.5 mEq/L)
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 |
|---|---|---|
| valsartan160 mg oral once in a day for initial 8 weeks and 320 mg, oral, once in a day for subsequent 16 weeks | Drug | valsartan |
Primary outcome
The percent change of urinary angiotensinogen excretion between at baseline and at 24 weeks after valsartan treatment.
Time frame: 4 weeks of screening periods + 24 weeks of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2009.
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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.
Yoon-Goo Kim, Professor principal investigator
Division of Nephrology, 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 4 study testing valsartan in people with Chronic Kidney Disease and Proteinuria, run by Samsung Medical Center 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 5 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: status not confirmed, as of the sponsor's last update on 9 Mar 2009. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Yoon-Goo Kim, Professor (82-2-3410-3442, ygkim26@skku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percent change of urinary angiotensinogen excretion between at baseline and at 24 weeks after valsartan treatment. (time frame: 4 weeks of screening periods + 24 weeks of treatment). 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 9 Mar 2009.