Observational Study to Evaluate the Safety and Efficacy of Kremezin IDT/Fine Gran in Progressive Chronic Kidney Disease Patients.
A Multi-center, Prospective, Observational Study to Evaluate the Safety and Efficacy of Kremezin IDT/Fine Gran in Progressive Chronic Kidney Disease Patients.
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.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Yongan Jeong
- Telefonnummer: +82-31-5176-4673
- E-post: yongan.jeong@inno-n.com
Studera Kontakt Backup
- Namn: Nayoung Lee
- Telefonnummer: +82-31-5176-4675
- E-post: nayoung.lee1@inno-n.com
Studieorter
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Seoul, Sydkorea
- Rekrytering
- HK inno.N
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Kontakt:
- Ahrong Kim
- Telefonnummer: +82-31-5176-4666
- E-post: ahrong.kim@inno-n.com
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Kontakt:
- Nayoung Lee
- Telefonnummer: +82-31-5176-4675
- E-post: nayoung.lee1@inno-n.com
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
3125
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: OTHER
- Tidsperspektiv: PROSPECTIVE
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Proportion of participants with an effective overall assessment at Week 24
Tidsram: 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. |
Baseline to Week 24 (Week 24 ±3 weeks)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Proportion of participants with an effective overall assessment at Week 48
Tidsram: 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. |
Baseline to Week 48 (Week 48 ±4 weeks)
|
|
Change from baseline in serum creatinine (Scr) at Weeks 24 and 48
Tidsram: Baseline to Week 24 and Week 48
|
Change = Scr at Week 24 or Week 48 - Scr at baseline. |
Baseline to Week 24 and Week 48
|
|
Change from baseline in estimated glomerular filtration rate (eGFR) at Weeks 24 and 48
Tidsram: 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. |
Baseline to Week 24 and Week 48
|
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Mean treatment satisfaction score at Weeks 24 and 48
Tidsram: Week 24 and Week 48
|
Treatment satisfaction will be assessed on a 7-point scale, from 1 (extremely dissatisfied) to 7 (extremely satisfied). |
Week 24 and Week 48
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Urogenitala sjukdomar
- Patologiska processer
- Manliga urogenitala sjukdomar
- Njursjukdomar
- Urologiska sjukdomar
- Kvinnliga urogenitala sjukdomar
- Kvinnliga urogenitala sjukdomar och graviditetskomplikationer
- Kronisk sjukdom
- Sjukdomsegenskaper
- Njurinsufficiens
- Patologiska tillstånd, tecken och symtom
- Njurinsufficiens, kronisk
Andra studie-ID-nummer
- IN_KRM_N01
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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