Comparison of the therapeutic effect of the combination of IVIG and leflunomide compared to treatment with IVIG alone in patients with kidney transplant rejection due to BK virus.
Comparison of the combination of immunoglubulin (IVIG) and leflunomide with IVIG in patients with BK virus infection in kidney transplant patients
Design
A randomized controlled clinical trial on 30 people
Settings and conduct
Shiraz Organ Transplantation Hospital - monthly blood sampling to check creatinine and virus level
Participants/Inclusion and exclusion criteria
1. The experience of the first kidney transplant
2. Age of patients over 18 years
3. Lack of relationship between CKD patients and autoimmune diseases
Intervention groups
The combination of IVIG and leflunomide compared to IVIG in patients with BK virus infection in kidney transplant patients
Main outcome variables
BK viral load level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230214057417N1
Registration date:2023-11-23, 1402/09/02
Registration timing:retrospective
Last update:2023-11-23, 1402/09/02
Update count:0
Registration date
2023-11-23, 1402/09/02
Registrant information
Name
pedram abdizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3323 5117
Email address
dr.pedram.abdizadeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-15, 1399/11/27
Expected recruitment end date
2023-10-22, 1402/07/30
Actual recruitment start date
2021-02-15, 1399/11/27
Actual recruitment end date
2023-10-22, 1402/07/30
Trial completion date
2023-10-22, 1402/07/30
Scientific title
Comparison of the therapeutic effect of the combination of IVIG and leflunomide compared to treatment with IVIG alone in patients with kidney transplant rejection due to BK virus.
Public title
• Comparison of graft loss rate in patients receiving ivig drug with patients receiving ivig and leflunomide regimen.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
They were transplanted for the first time, and the age of the patients is over 18 years old, and the CKD patients were not in the field of autoimmune diseases.
Exclusion criteria:
Autoimmune diseases - Any drug side effects - Having a history of treatment due to BK VIRUS
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Actual sample size reached:
15
Randomization (investigator's opinion)
Randomized
Randomization description
kidney transplant patients with BK virus infection who meet the inclusion criteria will randomly allocated into 2 groups.Block permutation randomization will be used to assign groups. Patients participating in the research will be divided into two groups using blocks of 4 using the letters A and B (for the equality of the groups).One group will receive IVIG , and the other group will receive IVIG + leflunomide. For block permutation randomization, the sealed envelope method will be used with a random sequence.
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding is in a way that the participant does not know the type of actions that will be done for him; Also, the person analyzing does not know the action that is done in each group. But since the parameters are measured by the researcher, there will be no blinding.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
raja 8 , rajaee blvd
City
yasoyj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591968168
Approval date
2021-01-20, 1399/11/01
Ethics committee reference number
21031
Health conditions studied
1
Description of health condition studied
patients with BK virus infection in kidney transplant patients
ICD-10 code
T86.13
ICD-10 code description
Kidney transplant infectio
Primary outcomes
1
Description
It is a leading interventional research, and the patients studied were under transplant for the first time, and the patients were over 18 years old, and the CKD patients did not have autoimmune diseases, and at any time of the study, if the patients had an increase in the serum creatinine level, samples were taken. Kidneys are done and if any type of transplant rejection is reported, they will be excluded from the study. Patients will be excluded from the study if they have any side effects of medication, and if they have a history of treatment due to BK VIRUS, which of course did not happen in our study. and the serum BK VIRUS level was checked monthly by PCR method and the result was recorded.The implementation method was to randomly divide the patients into two groups, one group received IVIG and the other group received leflunomide in addition to IVIG. For all patients, IVIG made by Biotest in England, which contains 5 grams of immunoglobulin in 100 cc vials, with a dose of 300 mg/kg every 3 weeks for three doses, and for people who, in addition to IVIG, leflunomide, made by Erna Hayat Danesh, in the form of 20 tablets There are milligrams, in the first 5 days, 100 mg orally was prescribed and from the sixth day onwards, 40 mg orally was prescribed daily for three months. Before IVIG injection, 500 cc of normal saline was prescribed to the patients for hydration. The patients who received leflunamide stopped taking mycophenolate mofetil, and the dose of mycophenolate mofetil was halved for those who received only IVIG.Patients who were taking tacrolimus and cyclosporine continued to take these two drugs with the previous routine. Meanwhile, in case of taking these two drugs - cyclosporine and tacrolimus - during the study, the serum level of the drugs was measured monthly and the serum level of tacrolimus was 4-6 ng/ml and the serum level of cyclosporine was maintained at 10-60 ng/ml. At the end of the study, the results of the two mentioned groups were measured and compared in terms of serum levels, BK VIRUS, serum creatinine and graft loss.
Timepoint
The length of the treatment and study period of the patients is two months, and the serum BK VIRUS level was checked monthly by PCR method and the results were recorded.
Method of measurement
It is a leading interventional research, and the patients studied were under transplant for the first time, and the patients were over 18 years old, and the CKD patients did not have autoimmune diseases, and at any time of the study, if the patients had an increase in the serum creatinine level, samples were taken. Kidneys are done and if any type of transplant rejection is reported, they will be excluded from the study. Patients will be excluded from the study if they have any drug side effects, and they will also be excluded from the study if they have a history of treatment due to BK VIRUS, which of course did not happen in our study.
Secondary outcomes
empty
Intervention groups
1
Description
Control group: In the present study, kidney transplant patients with BK virus infection were randomly divided into two groups. One group received IVIG and the other group received leflunomide in addition to IVIG. Before IVIG injection, 500 cc of normal saline was administered to all patients for hydration. IVG drug (Biotest company of England) is available in 100 cc vials containing 5 grams of immunoglobulin. In the first group, IVG drug was injected with a dose of 300 mg/kg once every 3 weeks (for three times).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
namazi hospital
Full name of responsible person
pedram abdizadeh
Street address
raja8 , rajaee blvd
City
yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591968168
Phone
+98 74 3233 5117
Email
dr.pedramabdizadeh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
dr. nakisa rasaee
Street address
raja8 , rajaee blvd
City
yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591968168
Phone
+98 74 3233 5117
Email
dr.pedram.abdizadeh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shiraz Renal Research Center
Proportion provided by this source
70
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
pedram abdizadeh
Position
Internal medicine specialist
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
raja 8 , rajaee blvd
City
yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591968168
Phone
+98 74 3233 5117
Email
dr.pedram.abdizadeh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
pedram abdizadeh
Position
Internal medicine specialist
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
raja8 ,rajaee blvd
City
yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591968168
Phone
+98 74 3233 5117
Email
dr.pedram.abdizadeh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
pedram abdizadeh
Position
Internal medicine specialist
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
raja 8 , raja blvd
City
yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591968168
Phone
+98 74 3233 5117
Email
dr.pedram.abdizadeh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Not applicable
Informed Consent Form
No - There is not 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
Undecided - It is not yet known if there will be a plan to make this available