Observational Study to Evaluate the Safety and Efficacy of Kremezin IDT/Fine Gran in Progressive Chronic Kidney Disease Patients.
Chronic Kidney Disease
What this study involves
The registry says this study is recruiting. Individual locations may have different availability.
- Study type
- Observational
- Phase
- Not applicable / not listed
- Age range
- 19 years - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 3125 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
This study will be conducted under routine clinical practice in adults diagnosed with advanced chronic renal failure for whom treatment with Kremezin immediate-release tablets or Kremezin fine granules has been determined as part of standard clinical care. Kremezin will be prescribed and administered in accordance with the approved product labeling. Study data will be collected at up to three time points through Week 48: baseline, Week 24, and Week 48. Effectiveness will be assessed using serum creatinine (Scr), estimated glomerular filtration rate (eGFR), and the investigator's overall assessment; treatment satisfaction and safety information will also be collected.
Read the full description
This is a multicenter, prospective, observational study to evaluate the effectiveness and safety of Kremezin immediate-release tablets or Kremezin fine granules in adults diagnosed with advanced chronic renal failure. During routine clinical visits, the investigator will determine whether Kremezin treatment is appropriate. The investigator will prescribe the selected formulation in accordance with the product labeling and routine clinical practice. The treatment decision must be made before the participant provides consent to participate in the study and without any study-related intervention.
Adults will receive Kremezin immediate-release tablets or fine granules at the approved dosage-2 g three times daily (4 tablets per dose or 1 sachet per dose, respectively)-for the treatment period determined in routine care, with study data collected through Week 48. Scr and eGFR will be recorded at baseline, Week 24 (±3 weeks), and Week 48 (±4 weeks). At Weeks 24 and 48, the investigator will also assess overall effectiveness and treatment satisfaction and collect safety information. Blood pressure and laboratory results will be collected when available. The study will not require additional treatment or visits beyond routine clinical care.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
Inclusion Criteria:
- Adults aged 19 years or older diagnosed with advanced chronic renal failure.
- Individuals who voluntarily decide to participate and provide written informed consent.
Exclusion Criteria:
- Individuals for whom Kremezin immediate-release tablets or Kremezin fine granules are contraindicated according to the product labeling.
- Individuals with AST or ALT levels at least three times the upper limit of normal.
- Individuals with chronic alcoholism.
- Individuals with an active or progressive infection.
- Pregnant or breastfeeding individuals.
- Individuals with a history of dialysis.
Study population
3125
Understand screeningTreatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not reported
- Masking
- Not reported
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Proportion of participants with an effective overall assessment at Week 24
Time frame: Baseline to Week 24 (Week 24 ±3 weeks)
Overall effectiveness will be assessed by the investigator based on serum creatinine (Scr) and estimated glomerular filtration rate (eGFR). Participants will be classified as effective, ineffective, or unevaluable; unevaluable participants will be excluded from the analysis.
Secondary measures
Proportion of participants with an effective overall assessment at Week 48
Time frame: Baseline to Week 48 (Week 48 ±4 weeks)
Overall effectiveness will be assessed by the investigator based on Scr and eGFR. Participants will be classified as effective, ineffective, or unevaluable; unevaluable participants will be excluded from the analysis.
Change from baseline in serum creatinine (Scr) at Weeks 24 and 48
Time frame: Baseline to Week 24 and Week 48
Change = Scr at Week 24 or Week 48 - Scr at baseline.
Change from baseline in estimated glomerular filtration rate (eGFR) at Weeks 24 and 48
Time frame: Baseline to Week 24 and Week 48
eGFR will be calculated using the CKD-EPI equation. Change = eGFR at Week 24 or Week 48 - eGFR at baseline.
Mean treatment satisfaction score at Weeks 24 and 48
Time frame: Week 24 and Week 48
Treatment satisfaction will be assessed on a 7-point scale, from 1 (extremely dissatisfied) to 7 (extremely satisfied).
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
HK inno.NSeoul, South KoreaRecruiting
Study team and timeline
- Lead sponsor
- HK inno.N Corporation
- Study start
- Jul 18, 2023 Actual
- Primary completion
- Dec 31, 2027 Estimated
- Study completion
- Dec 31, 2027 Estimated
- First posted
- Nov 10, 2026 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
A Multi-center, Prospective, Observational Study to Evaluate the Safety and Efficacy of Kremezin IDT/Fine Gran in Progressive Chronic Kidney Disease Patients.
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026