• 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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230214057417N1

Enrollment

Registered

2023-11-23

Start date

2021-02-15

Completion date

Unknown

Last updated

2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patients with BK virus infection in kidney transplant patients. Kidney transplant infectio

Interventions

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 addit

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion 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

Exclusion criteria: Autoimmune diseases - Any drug side effects - Having a history of treatment due to BK VIRUS

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Iran (Islamic Republic of)

Contacts

Public Contactpedram abdizadeh

Shiraz University of Medical Sciences

dr.pedram.abdizadeh@gmail.com+98 74 3233 5117

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026