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Post-marketing clinical evaluation study of Idavir peritoneal dialysis solution

Post-marketing clinical evaluation study of Idavir peritoneal dialysis solution

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100044720
Enrollment
Unknown
Registered
2021-03-26
Start date
2020-05-12
Completion date
Unknown
Last updated
2022-12-05

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

Conditions

End-stage renal disease stage 5

Interventions

Group 1 vs. Group 2: Idavir and Baxter peritoneal dialysis solution

Sponsors

The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital of Shandong Province)
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 years, no gender limit; 2. Diagnosed as end-stage renal disease; 3. The peritoneal dialysis treatment mode is CAPD; 4. Peritoneal dialysis time >= 30 days or new start of peritoneal dialysis; 5. Be able to perform standard home dialysis treatment; 6. Sign the written informed consent.

Exclusion criteria

Exclusion criteria: 1. Acute renal failure; 2. Prepare to receive a kidney transplant within half a year; 3. Hemodialysis; 4. There is acute or chronic exit infection or tunnel infection; 5. Suffered from peritonitis 30 days before the screening visit (2 out of 3 conditions are met, hereinafter referred to as peritonitis): (1) Abdominal pain, turbid ascites, with or without fever; (2) The white blood cell count in the exudate > 100 x 10^6/L, and the proportion of neutrophils > 50%; (3) The growth of pathogenic microorganisms in the permeate; 6. Known allergy to peritoneal dialysate components; 7. Suffering from other serious diseases such as active, or treated residual malignant tumor or systemic infection, liver cirrhosis, congestive heart failure, anemia (Hb 100kg or weight < 40kg); 9. Poor compliance, unable to treat according to the plan; 10. Pregnant or breast-feeding, women of childbearing age do not agree to use effective contraceptive measures during the trial; 11. History of alcohol and drug abuse (defined as the use of illegal drugs); 12. Any other circumstances in which the investigator believes that the patient cannot join the trial.

Design outcomes

Primary

MeasureTime frame
Ultrafiltration capacity;Urea clearance index;

Countries

China

Contacts

Public ContactXu Dongmei

The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital of Shandong Province)

xudongmei63@163.com+86 13395312810

Outcome results

None listed

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