Transfer factor in Chronic Kidney Disease

Phase 2

• Conditions: Stage 5 Chronic Kidney Disease under an iterated hemodialysis regimen; Kidney Failure, Chronic; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases

• Registration Number: RPCEC00000328
• Lead Sponsor: Center for Genetic Engineering and Biotechnology (CIGB), in Havana

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-06
• Study Completion: 2021-07-15
• Results First Posted: 2021-12-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1) Patients who meet the diagnostic criteria.
2) Patients of any sex, with an age greater than or equal to 18 years.
3) Stable patients, with more than 3 months and less than 3 years, on hemodialysis.
4) Patients who express their consent in writing, to participate in the study.

Exclusion Criteria

1) Patients who have received treatment with HEBERTRANS in the previous three months.
2) Patients with known hypersensitivity to any component of the formulation.
3) Patients with acute allergic states or history of severe allergic reactions.
4) Patients under immunosuppressive treatment at the time of the study.
5) Patients with hemoglobin less than or equal to 90 g / L.
6) Patients with uncontrolled intercurrent diseases, acute infections with concomitant febrile symptoms, symptomatic congestive heart failure, unstable angina pectoris, among others.
7) Patients in kidney transplant program.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cellular immune response: Concentration of leukocyte populations (lymphocyte subpopulations; T lymphocytes: CD3, CD4 (CD3 + / CD4 +), CD8 (CD3 + / CD8 +), CD4 / CD8 ratio; B lymphocytes: (CD19 +); NK / NKT cells: (CD3 -CD56 + / CD3 + CD56 +)). Measurement time: at baseline and, at weeks 9 and 17.