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A prospective, randomized, parallel-controlled multicenter clinical study of coated aldehyde oxystarch capsules in the treatment of CKD3 and above chronic kidney disease

A prospective, randomized, parallel-controlled multicenter clinical study of coated aldehyde oxystarch capsules in the treatment of CKD3 and above chronic kidney disease

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052024
Enrollment
Unknown
Registered
2021-10-14
Start date
2021-11-01
Completion date
Unknown
Last updated
2022-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic kidney disease

Interventions

Uric poisonous clear group:Basic treatment and urine duqing granules 5g three times a day
Coated aldehyde oxystarch capsules group 1:Basic treatment and coated aldehyde oxystarch capsules 8 capsules three times a day
Coated aldehyde oxystarch capsules group two:Basic treatment and coated aldehyde oxystarch capsules 12 capsules three times a day

Sponsors

The Second Hospital of Tianjin Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Chronic kidney disease diagnosed by renal function examination as stage 3 or above CKD3; 2. Aged 18-80 years; 3. BUN >= 8.9 mmol/L; 4. The patients had not taken aldeoxystarch capsule before enrollment or had stopped taking aldeoxystarch capsule 2 weeks before enrollment; 5. Patients voluntarily participated in the study and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Dyspepsia, acute and chronic gastroenteritis, reflux esophagitis, diarrhea of unknown cause; 2. Anorexia, ulcerative colitis, gastrointestinal tumor; 3. Intestinal obstruction; 4. Cirrhosis, esophageal varices, gastrointestinal bleeding; 5. Patients with acute cardiac insufficiency; 6. Allergic to aldoxystarch or urine duqing granules; 7. Subjects who are unable or unwilling to use adequate contraception during breastfeeding, pregnancy and study (including men); 8. Participating in another clinical investigator; 9. Patients considered unsuitable for inclusion by the investigator.

Design outcomes

Primary

MeasureTime frame
Renal function;

Secondary

MeasureTime frame
Electrolyte;Calcium phosphate magnesium;Blood sugar;Blood fat;Routine urine;Routine blood;Serum iron;Transferrin;

Countries

China

Contacts

Public ContactLi Rong

The Second Hospital of Tianjin Medical University

beilloa@souhu.com+86 18698061623

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026