Chronic Renal FailurePhase 4NCT02681952
A Multicenter, Randomized, Open-labeled, Cross-over, Active-controlled, Phase IV Clinical Trial to Evaluate the Preference of Formulation and the Efficacy and Safety of Renamezin and Kremezin in Pre-dialysis Patients With Chronic Renal Failure
A Phase 4 study testing Renamezin capsule and Kremezin granule in people with Chronic Renal Failure, run by Daewon Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
A Multicenter, Randomized, Open-labeled, Cross-over, Active-controlled, Phase IV Clinical Trial to Evaluate the Preference of Formulation and the Efficacy and Safety of Renamezin and Kremezin in Pre-dialysis Patients With Chronic Renal Failure Read more about this study
- Who is it for?
- Ages 20 to 74 years
- Conditions the study is for
- Chronic Renal Failure
- What is being tested?
- Renamezin capsule and Kremezin granule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2015to Dec 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 20 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pre-dialysis patients with chronic renal failure stage
- patient for holding the stable state in serum creatinine 2.0mg/dl - 5.0mg/dl of MDRD GFR 15-60ml/min/1.73m2 for 3 months before screening
- patients haven't experienced dose spherical carbon adsorbent for 3months before screening
- patients who were no noticeable change for 4weeks before screening and are expected to change is not needed during therapy in the therapy of chronic renal failure(type of blood pressure medication and dose -related, diet therapy)
- patients spontaneously written consent to participate in this clinical trial
Who cannot join
- patients with passes through the digestive tract disorders
- patients with uncontrolled constipation symptoms
- kidney transplant patients
- patients who are taking immunosuppressive drugs
- patients suffering from digestive tract ulcers and esophageal varices
- patients with uncontrolled hypertension
Show all 19Show fewer
- patients hospitalized with cardiovascular disease within 3 months of the screening
- patients with current infections
- patients who do not fulfill therapies of chronic renal failure (taking medicine and diet) as appropriate
- patients with hepatic impairment (2.5 times greater than the upper limit of normal levels of AST, ALT)
- uncontrolled diabetes (HbA1c > 10 % or a fasting glucose > 180mg / dL)
- patients with malignant tumors (However, if you do not relapse within five years after completion of therapy can be registered)
- pregnant women, nursing mothers
- those who do not agree to a contraceptive method allowed for the possibility of pregnancy in women
- patients participating in another clinical trial in addition to the current clinical trial
- subjects with dependency on drugs or alcohol
- subjects who took any other investigational drugs within 30 days before participating this clinical trial study
- patients expected to starting the dialysis within three months
- other patients deemed unsuitable tester
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Sevrance Hospital of Yonsei University
Seoul, Seodaemun, 03722
About this study
A Multicenter, Randomized, Open-labeled, Cross-over, Active-controlled, Phase IV Clinical Trial to Evaluate the Preference of Formulation and the Efficacy and Safety of Renamezin and Kremezin in Pre-dialysis Patients With Chronic Renal Failure
- Conditions
- Chronic Renal Failure
- Being tested
- Renamezin capsule, Kremezin granule
- 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
Kremezin granuleDrug
| Study group | Role | What they receive |
|---|---|---|
| Renamezin->Kremezin | Active comparator | Not described Receives: Drug: Renamezin capsule; Drug: Kremezin granule |
| Kremezin->Renamezin | Active comparator | Not described Receives: Drug: Renamezin capsule; Drug: Kremezin granule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preference of formulation
questionnaire
Measured: 24weeks
Secondary outcomes (4)
Serum Creatinine
Measured: 12weeks, 24weeks
Serum Indoxyl sulfate
Measured: 12weeks, 24weeks
Cystatin-C
Measured: 12weeks, 24weeks
estimated GFR(Glomerular Filtration Rate)
MDRD GFR
Measured: 12weeks, 24weeks
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 startDec 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daewon Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bumseok Kim, Professor, Principal investigator, Sevrance Hospital of Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02681952
- Sponsor's protocol ID
- DW_RNMZ_401
- Status last verified
- Jul 2017
- First submitted
- 10 Feb 2016
- Last updated
- 6 Jul 2017
- Results posted
- No
Publications
Kee YK, Han SY, Kang DH, Noh JW, Jeong KH, Kim GH, Kim YW, Kim BS. Comparison of Different Types of Oral Adsorbent Therapy in Patients with Chronic Kidney Disease: A Multicenter, Randomized, Phase IV Clinical Trial. Yonsei Med J. 2021 Jan;62(1):41-49. doi: 10.3349/ymj.2021.62.1.41.
PubMed 33381933
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
- A Multicenter, Randomized, Open-labeled, Cross-over, Active-controlled, Phase IV Clinical Trial to Evaluate the Preference of Formulation and the Efficacy and Safety of Renamezin and Kremezin in Pre-dialysis Patients With Chronic Renal Failure
- ClinicalTrials.gov ID
- NCT02681952
- Acronym / sponsor ID
- DW_RNMZ_401
- Conditions
- Chronic Renal Failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Daewon Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 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.
A Multicenter, Randomized, Open-labeled, Cross-over, Active-controlled, Phase IV Clinical Trial to Evaluate the Preference of Formulation and the Efficacy and Safety of Renamezin and Kremezin in Pre-dialysis Patients With Chronic Renal Failure
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Renamezin->Kremezin | Active comparator | Drug: Renamezin capsule, Drug: Kremezin granule |
| Kremezin->Renamezin | Active comparator | Drug: Renamezin capsule, Drug: Kremezin granule |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- pre-dialysis patients with chronic renal failure stage
- patient for holding the stable state in serum creatinine 2.0mg/dl - 5.0mg/dl of MDRD GFR 15-60ml/min/1.73m2 for 3 months before screening
- patients haven't experienced dose spherical carbon adsorbent for 3months before screening
- patients who were no noticeable change for 4weeks before screening and are expected to change is not needed during therapy in the therapy of chronic renal failure(type of blood pressure medication and dose -related, diet therapy)
- patients spontaneously written consent to participate in this clinical trial
Key exclusion criteria (19 listed)
- patients with passes through the digestive tract disorders
- patients with uncontrolled constipation symptoms
- kidney transplant patients
- patients who are taking immunosuppressive drugs
- patients suffering from digestive tract ulcers and esophageal varices
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 | Kremezin->Renamezin, Renamezin->Kremezin |
| Kremezin granule | Drug | Kremezin->Renamezin, Renamezin->Kremezin |
Primary outcome
Preference of formulation
Time frame: 24weeks
questionnaire
4 secondary outcomes
Serum Creatinine
Time frame: 12weeks, 24weeks
Serum Indoxyl sulfate
Time frame: 12weeks, 24weeks
Cystatin-C
Time frame: 12weeks, 24weeks
estimated GFR(Glomerular Filtration Rate)
Time frame: 12weeks, 24weeks
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.
- Derived from this study: PubMed 33381933Kee YK, Han SY, Kang DH, Noh JW, Jeong KH, Kim GH, Kim YW, Kim BS. Comparison of Different Types of Oral Adsorbent Therapy in Patients with Chronic Kidney Disease: A Multicenter, Randomized, Phase IV Clinical Trial. Yonsei Med J. 2021 Jan;62(1):41-49. doi: 10.3349/ymj.2021.62.1.41.
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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.
Bumseok Kim, Professor principal investigator
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 and Kremezin granule 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 5 inclusion and 19 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?
Preference of formulation (time frame: 24weeks). 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 NCT02681952, which also lists 1 linked publication.
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; AzTrials last refreshed its copy on 27 Oct 2026.