drugset / Trial / NCT02966717

Rituximab Combined With MSCs in the Treatment of PNS (3-4 Stage of CKD)

NCT02966717

Phase 2 Unknown 116 enrolled Zhujiang Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

Primary nephrotic syndrome(PNS) is a group of clinical symptoms caused by a variety of factors, including immune,environmental, genetic, et al. Oral corticosteroids have been to be the preferred drug for the treatment of PNS, but the long-term use of glucocorticoid therapy in clinic often induces some problems such as hormone dependent and hormone resistance, as well as severe side effects which act as a threat to the patients' health. Besides, patients with proteinuria long-term not control often behave faster progression into chronic renal failure, leading to poor prognosis. In renal diseases, Rituximab ( RTX) is often used in the treatment of refractory nephropathy, such as hormone dependent nephrotic syndrome, hormone resistance nephrotic syndrome, frequency recurrence nephrotic syndrome, which shows exciting effects in delaying the development of the disease.At present, mesenchymal stem cells ( MSCs) has been used as a research hotspot to repair the tissue damage of chronic kidney disease, and it also behaves certain effects. The purpose of this study is to seek a more targeted treatment, more precise curative effect and more feasibility treatment for PNS(CKD3-4),so as to delay or reverse the disease and improve the quality of life of patients with CKD.

Timeline

Start
2016-08
Primary completion
2016-10
Completion
2021-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Rituximab Monoclonal antibody 100 mg
Subject mesenchymal stem cells Cell therapy 1e+06 cells/kg
Comparator Amlodipine Other / unclassified
Comparator Metoprolol Other / unclassified
Comparator Terazosin Small molecule
Comparator Valsartan Small molecule
Comparator bailing capsule Unknown