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

NCT02966717 | Unknown Phase 2 DMC

• 1 other identifier: Tangxun8022
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Renal Insufficiency, Chronic; Nephrotic Syndrome

Keywords

Rituximab; Mesenchymal stem cells; primary nephrotic syndrome; chronic kidney disease

Outcome Measures

Primary Outcomes (2)

• The change of serum creatinine elevation

  The serum creatine elevation should be tested for at least 4 times, as follows, before treatment, 4 weeks after treatment, 8 weeks after treatment, 12 weeks after treatment.

  4 weeks, 8 weeks, 12 weeks

• The percentage of end-stage renal disease or death.

  The percentage of end-stage renal disease or death should be less than 60%.

  3 years

Study Arms (2)

parallel control of conventional therapy

ACTIVE COMPARATOR

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.

Drug: conventional therapy

experimental group

EXPERIMENTAL

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.

Drug: Rituximab; Drug: Mesenchymal stem cells

Interventions

Rituximab DRUG

Rituximab is a human-mouse-chimeric monoclonal antibody which was approved in 1997 for the treatment of cancer.

Also known as: Mabthera, RTX, Rituxan

experimental group

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.

parallel control of conventional therapy

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.

Also known as: MSCs

experimental group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (1)

Zhujiang Hospital, Southern Medical University

Guangzhou, Guangdong, 510282, China

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Nephrotic Syndrome

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nephrosis

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Tang Xun, doctor

  Zhujiang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2016
• First Posted: November 17, 2016
• Study Start: August 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2021
• Last Updated: November 22, 2016

Record last verified: 2016-11

Locations

CN (1)