Chronic Renal FailurePhase 4NCT02681991
Phase Ⅳ Clinical Trial to Evaluate of Renamezin in Patients With Chronic Renal Failure.
A Phase 4 study testing Renamezin capsule in people with Chronic Renal Failure, run by Daewon Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
Renamezin Capsule (an oral adsorbent) lowers indoxyl sulfate levels in patient with chronic renal failure. 120 patients with chronic renal failure(baseline serum creatinine:1.5-5.0mg/dl). Renamezin is administered 6.0mg/day. The treatment period is 2 months. The change in serum indoxyl sulfate will be evaluated. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Chronic Renal Failure
- What is being tested?
- Renamezin capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2016to Sep 2016
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients spontaneously written consent to participate in this clinical trial
- men and women over age of 19
- pre-dialysis patients with chronic renal failure stage patient for 3 months and patients for holding the stable state in serum creatinine 1.5mg/dl - 5.0mg/dl
- patients who were no noticeable change for 12weeks before screening and are expected to change is not needed during therapy in the therapy of chronic renal failure(medication and dose -related, diet therapy)
Who cannot join
- patients with passes through the digestive tract disorders
- patients with uncontrolled constipation symptoms
- patients suffering from digestive tract ulcers and esophageal varices
- patients with untreated severe hypertension (DBP ≥ 120mmHg)
- patients hospitalized with angina pectoris, cardiovascular disease or diagnosed with serious arrhythmia or cerebrovascular disease within 6 months
- patients with hepatic impairment (2 times greater than the upper limit of normal levels of AST, ALT)
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- subjects with dependency on alcohol
- patients with current infections
- pregnant women, nursing mothers
- Patients with a possibility of pregnancy (However, negative case can be registered)
- patients participating in another clinical trial in addition to the current clinical trial
- Patient who do not fit the clinical trial participation the legal and mentally
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Gangnam Sevrance Hospital of Yonsei University
Seoul, Gangnam-gu, 06273
About this study
Renamezin Capsule (an oral adsorbent) lowers indoxyl sulfate levels in patient with chronic renal failure.
120 patients with chronic renal failure(baseline serum creatinine:1.5-5.0mg/dl).
Renamezin is administered 6.0mg/day. The treatment period is 2 months. The change in serum indoxyl sulfate will be evaluated.
- Conditions
- Chronic Renal Failure
- Being tested
- Renamezin capsule
- 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.
Renamezin capsuleDrug
| Study group | Role | What they receive |
|---|---|---|
| test | Experimental | Renamezin capsule 2g, tid, PO Receives: Drug: Renamezin capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline of Indoxyl sulfate at 8weeks
Measured: 0, 8weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionSep 2016
- Study completionSep 2016
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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daewon Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Hyeong-Cheon Park, Gangnam Severance Hospital
- Investigators
- Hyeong-Cheon Park, Professor, Principal investigator, Gangnam Sevrance Hospital of Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02681991
- Sponsor's protocol ID
- RNM-001
- Status last verified
- Jul 2017
- First submitted
- 10 Feb 2016
- Last updated
- 6 Jul 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ⅳ Clinical Trial to Evaluate of Renamezin in Patients With Chronic Renal Failure.
- ClinicalTrials.gov ID
- NCT02681991
- Acronym / sponsor ID
- RNM-001
- Conditions
- Chronic Renal Failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Daewon Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 15 Feb 2016 (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.
Renamezin Capsule (an oral adsorbent) lowers indoxyl sulfate levels in patient with chronic renal failure.
120 patients with chronic renal failure(baseline serum creatinine:1.5-5.0mg/dl).
Renamezin is administered 6.0mg/day. The treatment period is 2 months. The change in serum indoxyl sulfate will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| test | Experimental | Drug: Renamezin capsuleRenamezin capsule 2g, tid, PO |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients spontaneously written consent to participate in this clinical trial
- men and women over age of 19
- pre-dialysis patients with chronic renal failure stage patient for 3 months and patients for holding the stable state in serum creatinine 1.5mg/dl - 5.0mg/dl
- patients who were no noticeable change for 12weeks before screening and are expected to change is not needed during therapy in the therapy of chronic renal failure(medication and dose -related, diet therapy)
Key exclusion criteria (12 listed)
- patients with passes through the digestive tract disorders
- patients with uncontrolled constipation symptoms
- patients suffering from digestive tract ulcers and esophageal varices
- patients with untreated severe hypertension (DBP ≥ 120mmHg)
- patients hospitalized with angina pectoris, cardiovascular disease or diagnosed with serious arrhythmia or cerebrovascular disease within 6 months
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 |
|---|---|---|
| Renamezin capsule | Drug | test |
Primary outcome
change from baseline of Indoxyl sulfate at 8weeks
Time frame: 0, 8weeks
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 6 Jul 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.
Hyeong-Cheon Park, Professor principal investigator
Gangnam Sevrance Hospital of Yonsei University
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 Renamezin capsule in people with Chronic Renal Failure, run by Daewon 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 4 inclusion and 12 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 Jul 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. 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?
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?
change from baseline of Indoxyl sulfate at 8weeks (time frame: 0, 8weeks). 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 6 Jul 2017.