Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

Coated Aldehyde Oxystarch for Protein-Bound Uremic Toxin Reduction in End-Stage Renal Disease

12 juni 2026 uppdaterad av: Liangying Gan, MD, Peking University People's Hospital

An Exploratory, Single-Center, Self-Controlled Trial of Coated Aldehyde Oxystarch for Reducing Protein-Bound Uremic Toxins in Patients With End-Stage Renal Disease

The goal of this clinical trial is to learn if Coated Aldehyde Oxystarch (Xiqing) works to reduce protein-bound uremic toxins (PBUTs) in adults with end-stage renal disease (ESRD). It will also learn about the safety of Coated Aldehyde Oxystarch. The main questions it aims to answer are:

Does Coated Aldehyde Oxystarch lower the blood levels of protein-bound uremic toxins, such as indoxyl sulfate and p-cresyl sulfate?

What medical problems do participants have when taking Coated Aldehyde Oxystarch?

Researchers will compare the levels of PBUTs before treatment (baseline) with those after treatment with Coated Aldehyde Oxystarch to see if it works to reduce these toxins.

Participants will:

Take Coated Aldehyde Oxystarch (Xiqing) 10 capsules per time, three times daily (each capsule 0.625 g, total daily dose 18.75 g) for 3 months.

Visit the clinic every month for checkups and blood tests.

Provide blood samples to measure protein-bound uremic toxin levels and routine safety parameters.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Patients with end-stage renal disease (ESRD) have high morbidity and mortality. Current dialysis poorly clears protein-bound uremic toxins (PBUTs) such as indoxyl sulfate (IS), which is associated with adverse outcomes. Coated Aldehyde Oxystarch is an oral adsorbent that binds IS in vitro, but its in vivo effect is unknown. This study aims to rigorously explore the effect of Coated Aldehyde Oxystarch on reducing serum IS and other PBUTs in maintenance hemodialysis patients. This is the first in vivo study to evaluate the effect of Coated Aldehyde Oxystarch on reducing protein-bound uremic toxins (particularly indoxyl sulfate) in patients with end-stage renal disease, offering a novel intestinal-targeted strategy to mitigate toxin accumulation in dialysis patients.

Studietyp

Interventionell

Inskrivning (Beräknad)

30

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Kina
      • Beijing, Kina
        • Rekrytering
        • Peking University People's Hospital
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

Inclusion Criteria:

  • Age ≥ 18 years, no restriction on sex or ethnicity.
  • Receiving maintenance dialysis for at least 3 months, with dialysis regimen remaining unchanged during the trial period.
  • If taking other medications that do not interfere with gut microbiota prior to enrollment, they must have been stable for at least 1 month and the regimen must remain unchanged during the trial.
  • Ability to understand and voluntarily sign the informed consent form.

Exclusion Criteria:

  • Known allergy to Coated Aldehyde Oxystarch.
  • History of or planned kidney transplantation within 6 months, or change in dialysis regimen.
  • Use of medications or supplements that may affect gut microbiota (e.g., antibiotics, probiotics, prebiotics, laxatives) within the past 3 months.
  • Diagnosis of serious gastrointestinal diseases, including gastrointestinal bleeding, colitis, inflammatory bowel disease, irritable bowel syndrome, history of intestinal obstruction, history of gastrectomy or duodenectomy.
  • History of cardiovascular or cerebrovascular events within 3 months prior to screening, including hospitalization for stroke, myocardial infarction, unstable angina, congestive heart failure; severe valvular stenosis, uncontrolled atrial fibrillation or arrhythmia; QTc interval >500 ms on repeated ECG.
  • Concurrent severe primary diseases of cardiovascular, cerebrovascular, hepatic, hematopoietic systems, or other known life-threatening diseases (e.g., malignancy, AIDS), or patients with mental or legal disabilities.
  • Investigator judges life expectancy ≤6 months.
  • Inability to maintain stable dietary habits during the study period.
  • Inability to maintain original dialysis regimen during the study period.
  • Use of Chinese patent medicines for kidney disease (e.g., Shenkang Injection, Haikun Shenxi Capsule, Shenshuaining, Tripterygium preparations, Niaoduqing Granules) within 1 month prior to enrollment.
  • Participation in another clinical trial within the past 1 month.
  • Intellectual disability, psychiatric disorders, or suspected/confirmed history of alcohol or drug abuse that may affect compliance.
  • Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Experimental: Coated Aldehyde Oxystarch (Xiqing)
Participants with end-stage renal disease (ESRD) will receive Coated Aldehyde Oxystarch (Xiqing) orally at a dose of 10 capsules (0.625g/capsule) three times daily for 3 months.
Läkemedel: Coated Aldehyde Oxystarch
Each capsule contains 0.625g of Coated Aldehyde Oxystarch. Participants will take 10 capsules per time, three times daily for 3 months.
Andra namn:
  • Xiqing

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Absolute Change From Baseline in Serum Indoxyl Sulfate (IS) Level at Month 3
Tidsram: Baseline, Month 3
The absolute change in serum indoxyl sulfate (IS) level from baseline to Month 3 will be calculated as the serum IS level at Month 3 minus the serum IS level at baseline.
Baseline, Month 3
Percentage Change From Baseline in Serum Indoxyl Sulfate (IS) Level at Month 3
Tidsram: Baseline, Month 3
The percentage change in serum indoxyl sulfate (IS) level from baseline to Month 3 will be calculated as: [(serum IS level at Month 3 - serum IS level at baseline) / serum IS level at baseline] × 100%.
Baseline, Month 3

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Serum Indoxyl Sulfate (IS) Level Over Time
Tidsram: Baseline, Month 1, Month 2, Month 3
Change from baseline in serum IS level at Month 1 and Month 2, in addition to Month 3. The trend of changes over different time points will be analyzed.
Baseline, Month 1, Month 2, Month 3
Changes in Serum Phosphorus Levels
Tidsram: Baseline, Month 1, Month 2, Month 3
Change from baseline in serum phosphorus levels at Month 1, Month 2, and Month 3.
Baseline, Month 1, Month 2, Month 3
Changes in Serum Calcium Levels
Tidsram: Baseline, Month 1, Month 2, Month 3
Change from baseline in serum calcium levels at Month 1, Month 2, and Month 3.
Baseline, Month 1, Month 2, Month 3
Changes in Serum Potassium Levels
Tidsram: Baseline, Month 1, Month 2, Month 3
Change from baseline in serum potassium levels at Month 1, Month 2, and Month 3.
Baseline, Month 1, Month 2, Month 3
Change in High-Sensitivity C-Reactive Protein (hs-CRP) Level
Tidsram: Baseline, Month 1, Month 2, Month 3
Change from baseline in serum hs-CRP level at Month 1, Month 2, and Month 3.
Baseline, Month 1, Month 2, Month 3
Change From Baseline in Worst Itch Numeric Rating Scale Score Over Time
Tidsram: Baseline, Month 1, Month 2, Month 3
The change from baseline in pruritus severity associated with chronic kidney disease will be assessed using the Worst Itch Numeric Rating Scale at Month 1, Month 2, and Month 3. The Worst Itch Numeric Rating Scale ranges from 0 to 10, where 0 indicates no itch and 10 indicates the worst imaginable itch. Higher scores indicate more severe pruritus.
Baseline, Month 1, Month 2, Month 3

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Peking University People's Hospital

Utredare

  • Huvudutredare: Liangying Gan, MD, Renal Division, Department of Medicine, Peking University People's Hospital

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

21 april 2025

Primärt slutförande (Beräknad)

1 juli 2026

Avslutad studie (Beräknad)

1 augusti 2026

Studieregistreringsdatum

Först inskickad

23 maj 2026

Först inskickad som uppfyllde QC-kriterierna

12 juni 2026

Första postat (Faktisk)

17 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

17 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

12 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • 2025PHB032-001

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera