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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02966717
Recruitment Status : Unknown
Verified November 2016 by Zhujiang Hospital.
Recruitment status was:  Active, not recruiting
First Posted : November 17, 2016
Last Update Posted : November 22, 2016
Information provided by (Responsible Party):
Zhujiang Hospital

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.

Condition or disease Intervention/treatment Phase
Renal Insufficiency, Chronic Nephrotic Syndrome Drug: Rituximab Drug: conventional therapy Drug: Mesenchymal stem cells Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Clinical Study of Rituximab Combined With Mesenchymal Stem Cells in the Treatment of Primary Nephrotic Syndrome (3-4 Stage of Chronic Kidney Disease)
Study Start Date : August 2016
Actual Primary Completion Date : October 2016
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
Drug Information available for: Rituximab

Arm Intervention/treatment
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.
Drug: 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.
Drug: Rituximab
Rituximab is a human-mouse-chimeric monoclonal antibody which was approved in 1997 for the treatment of cancer.
Other Names:
  • Mabthera
  • RTX
  • Rituxan

Drug: Mesenchymal stem cells
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.
Other Name: MSCs

Primary Outcome Measures :
  1. The change of serum creatinine elevation [ Time Frame: 4 weeks, 8 weeks, 12 weeks ]
    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.

  2. The percentage of end-stage renal disease or death. [ Time Frame: 3 years ]
    The percentage of end-stage renal disease or death should be less than 60%.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Gender-Definition: Physical gender of individuals who may participate in the protocol. Select one-Both: both female and male participants are being studied.

Age Limits-Minimum Age( Definition: Minimum age of participants. ); Maximum Age (Definition: Maximum age of participants).

Accepts Healthy Volunteers?-Definition: Indicate if persons who have not had the condition(s) being studied or otherwise related conditions or symptoms, as specified in the eligibility requirements, may participate in the study.

Eligibility Criteria-Definition: Summary criteria for participant selection. The preferred format includes lists of inclusion and exclusion criteria as shown below.

Inclusion Criteria: A. Nephrotic syndrome(urine protein > 3.5g/d and serum albumin < 30g/L); B. 3-4 stage of CKD [glomerular filtration rate 15-59 ml/ (min ·1.73m²)]; C. Age should be 18-65 years old; D. Accept treatment and signe informed consent voluntarily.

- Exclusion Criteria:A. Secondary nephrotic syndrome such as systemic lupus erythematosis nephritis, anaphylactic purpura nephritis and diabetic nephropathy and so on; B. Complications like severe infection, cardiovascular diseases, severe heart and lung as well as liver complications; C. Dialysis is extremely urgent; D. Obstructive urinary tract diseases; E. Creatinine rises more than 30% of the based value in nearly 3 months; F. Pregnancy or in lactation; G. Any other conditions that researchers consider not suitable to participate in this trial.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02966717

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China, Guangdong
Zhujiang Hospital, Southern Medical University
Guangzhou, Guangdong, China, 510282
Sponsors and Collaborators
Zhujiang Hospital
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Principal Investigator: Tang Xun, doctor Zhujiang Hospital
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Responsible Party: Zhujiang Hospital Identifier: NCT02966717    
Other Study ID Numbers: Tangxun8022
First Posted: November 17, 2016    Key Record Dates
Last Update Posted: November 22, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Zhujiang Hospital:
Mesenchymal stem cells
primary nephrotic syndrome
chronic kidney disease
Additional relevant MeSH terms:
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Renal Insufficiency
Nephrotic Syndrome
Renal Insufficiency, Chronic
Pathologic Processes
Kidney Diseases
Urologic Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents