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Study on the efficacy and safety of thymopentin in preventing infection in patients with peritoneal dialysis

Study on the efficacy and safety of thymopentin in preventing infection in patients with peritoneal dialysis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049911
Enrollment
Unknown
Registered
2021-08-10
Start date
2019-05-01
Completion date
Unknown
Last updated
2022-04-19

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

Conditions

Chronic renal failure

Interventions

Group A:Thymopentin injection
Group B:Simple peritoneal dialysis

Sponsors

Ruijin Hosppital Affiliated to Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years old; 2. Diagnosis of Refractory ESRD and starting peritoneal dialysis regularly>=3 months; 3. Did not use hormones and immunosuppressive agents; 4. Female patients who have fertility must meet this condition: the test for HCG in blood or urine before enrollment was negative.

Exclusion criteria

Exclusion criteria: 1. Patients allergic to known study drugs; 2. Patients taking hormone and immunosuppressive therapy in recent half a yea; 3. Patients with severe heart disease, NYHA grade III-V; 4. Patients with known or suspected active tuberculosis; 5, Patients complicated with severe liver disease (ALT or AST continuously greater than 2 times the normal value); 6. Patients with new malignant tumor (within 5 years), or receiving radiotherapy/chemotherapy; 7. Patients with any known disease that severely affects the immune system, such as human immunodeficiency virus (HIV) infection, or splenectomy; 8. Patients with systemic lupus erythematosus (SLE) or combined SLE 9. Neutrophil count < 1500 /mm3 within 48 hours before inclusion; 10. Other researchers deem unsuitable to participate in this clinical trial; 11. The patient refused to participate in the study.

Design outcomes

Primary

MeasureTime frame
Infection Rate;

Secondary

MeasureTime frame
Serum IL-2, IL-6, IL-22 level before and after intervention;Serum T cell subsets (CD4, CD8, CD4/CD8) before and after intervention;Serum NK cell before and after intervention;Serum IgA, IgG, IgM level before and after intervention;SerumTNF-alpha level before and after intervention;

Countries

China

Contacts

Public ContactHong Ren

Ruijin Hosppital Affiliated to Shanghai Jiao Tong University School of Medicine

renhong66@126.com+86 13917333734

Outcome results

None listed

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