The purpose of this study is to investigate the treatment with Rituximab and compare it with the treatment with Cyclosporine in steroid-resistant Nephrotic Syndrome patients.
Design
The clinical trial was designed with parallel groups (two groups of 38 people), double-blind, randomized. The rand function of Excel software was used for randomization.
Settings and conduct
- Random selection of 76 people in two groups of 38 people
- The location of the study is related to patients referred to Hazrat Masoumeh Hospital in Qom.
- Patients who use Rituximab are not included in the group of patients with Cyclosporine treatment, and such a situation is also done for patients with Cyclosporine treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients from 1 to 18 years resistant to Nephrotic syndrome
Exclusion criteria:
Age above 18 years and below 1 year
Existence of anatomical problems
Intervention groups
This study will be conducted as a clinical intervention and control. The study population will include children with steroid-resistant Nephrotic syndrome referred to Hazrat Fatima Masoumeh (S) Hospital. The number of samples for reporting will be about 76 people which will include 38 people with Rituximab and 38 people with Cyclosporine. In the intervention group, each patient will receive 375 mg/m2/weekly of Rituximab for 1 to 4 doses, and in the other group, 4-5 mg/day/Kg of Cyclosporine twice a day for at least one year. The selection of groups will be based on a random process and there will be no intentionality in the selection of people.
Comparison of the effects of rituximab and cyclosporine on the treatment of patients aged 1 to 18 years with steroid-resistant nephrotic syndrome
Public title
The effects of Rituximab and Cyclosporine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Resistant to Nephrotic Syndrome
Exclusion criteria:
Age
From 1 year old to 18 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization;
Using two layers of treatment with Rituximab and treatment with Cyclosporine;
Randomization based on the table of random numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants are unaware of study group allocation. Also, the researchers are not aware of the study groups to investigate the recurrence or the impact of the disease.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qom University of Medical Sciences
Street address
Pardisan, The end of Ghadir Blvd, Educational complex of Qom University of Medical Sciences
City
Qom
Province
Ghoum
Postal code
3713649373
Approval date
2024-05-19, 1403/02/30
Ethics committee reference number
IR.MUQ.REC.1403.080
Health conditions studied
1
Description of health condition studied
Steroid-resistant nephrotic syndrome
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The effectiveness of the drug on the amount of edema
Timepoint
Finally, one year for each patient
Method of measurement
Clinical symptoms based on the degree of edema
2
Description
The effectiveness of the drug on the amount of albumin
Timepoint
Finally, one year for each patient
Method of measurement
Albumin - laboratory
3
Description
The effectiveness of the drug on blood cells
Timepoint
Finally, one year for each patient
Method of measurement
Counting blood cells - laboratory
4
Description
The effectiveness of the drug on the ratio of protein to creatinine
Timepoint
Finally, one year for each patient
Method of measurement
Measuring the ratio of Protein to Creatinine - laboratory
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The results of the tests
When the data will become available and for how long
After the publication of the thesis
To whom data/document is available
Researchers-Reviewers
Under which criteria data/document could be used
Written request to continue the investigation
From where data/document is obtainable
Applicants can access documents and data in three ways:
1- Refer to the thesis documentation unit (Library of Qom University of Medical Sciences)
2- Refer to the research and innovation department of Qom University of Medical Sciences
3- Correspondence with the responsible person's email listed on the thesis page
What processes are involved for a request to access data/document
Written request with the responsible person
Communication with the university