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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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28 November 2016 |
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Main ID: |
NCT02966717 |
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Date of registration:
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30/10/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Rituximab Combined With MSCs in the Treatment of PNS (3-4 Stage of CKD)
CKD |
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Scientific title:
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The Clinical Study of Rituximab Combined With Mesenchymal Stem Cells in the Treatment of Primary Nephrotic Syndrome (3-4 Stage of Chronic Kidney Disease) |
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Date of first enrolment:
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August 2016 |
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Target sample size:
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116 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02966717 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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China
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Contacts
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Name:
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Tang Xun, doctor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Zhujiang Hospital |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Renal Insufficiency, Chronic
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Nephrotic Syndrome
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Intervention(s)
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Drug: conventional therapy
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Drug: Rituximab
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Drug: Mesenchymal stem cells
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Primary Outcome(s)
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The change of serum creatinine elevation
[Time Frame: 4 weeks, 8 weeks, 12 weeks]
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The percentage of end-stage renal disease or death.
[Time Frame: 3 years]
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Secondary ID(s)
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Tangxun8022
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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