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

Sponsor
Zhujiang Hospital
Study ID
NCT02966717
Phase
PHASE2
Status
Unknown

Conditions

  • Nephrotic Syndrome
  • Renal Insufficiency, Chronic

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    Rituximab is a human-mouse-chimeric monoclonal antibody which was approved in 1997 for the treatment of cancer.
  • conventional therapy — DRUG
    Intervention of conventional therapy group: controlling blood pressure using amlodipine, valsartan, metoprolol and terazosin and so on , protecting the renal function using bailing capsule, alpha keto acid, low molecular weight heparin and so on.
  • Mesenchymal stem cells — DRUG
    Mesenchymal stem cells (MSCs), which belongs to mesoderm, is a kind of somatic stem cell with the ability of self-replication and the potential of multi-directional differentiation.

Study Details

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.

Key Dates

Start date
Aug 31, 2016
Status verified
Nov 2016
Primary completion
Oct 31, 2016
Completion
Oct 31, 2021

Study Design

Enrollment
116 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: parallel control of conventional therapy
    Intervention of conventional therapy group: controlling blood pressure using amlodipine, valsartan, metoprolol and terazosin and so on , protecting the renal function using bailing capsule, alpha keto acid, low molecular weight heparin and so on.
  • Experimental: experimental group
    Intervention of Rituximab combined with mesenchymal stem cells group: as follows, Rituximab, 100mg/time every one week, the infusion should be a total of 4 times; and then after at least 4 days interval after the first and the third infusion of the Rituximab , the dosage of mesenchymal stem cells tends to be 10\^6/kg/time every 2 weeks, while the infusion should be a total of 2 times.

Primary Outcome Measure

The change of serum creatinine elevation [ Time Frame: 4 weeks, 8 weeks, 12 weeks ]

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