]>
IRCT20230214057417N1 IRCT 2023-11-23 Shiraz University of Medical Sciences • Comparison of graft loss rate in patients receiving ivig drug with patients receiving ivig and leflunomide regimen. 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. 2021-02-15 anticipated 30 Complete https://irct.ir/trial/68636 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. N/A patients with BK virus infection in kidney transplant patients. 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).. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public pedram abdizadeh
raja 8 , rajaee blvd
yasouj Iran (Islamic Republic of) 7591968168 +98 74 3233 5117 dr.pedram.abdizadeh@gmail.com Shiraz University of Medical Sciences scientific pedram abdizadeh
raja8 ,rajaee blvd
yasouj Iran (Islamic Republic of) 7591968168 +98 74 3233 5117 dr.pedram.abdizadeh@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) 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. 18 years no limit Both Autoimmune diseases - Any drug side effects - Having a history of treatment due to BK VIRUS T86.13 Kidney transplant infectio Treatment - Drugs 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). 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. Shiraz Renal Research Center Approved 2021-01-20 Ethics committee of Shiraz University of Medical Sciences raja 8 , rajaee blvd yasoyj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)