Comparing plasmapheresis+IVIg vs plasmapheresis+IVIg+ High dose rituximab vs plasmapheresis+IVIg+ Low dose rituximab on the management of antibody-mediated rejection in kidney transplant recipients
The aim of the study: Recognizing the best treatment regimen to reach better graft survival, lower adverse effects and lower cost based on the medications which are existed in Iran's pharmacopea. Study design: Non-randomized, non-parallel group, open-label clinical study. a- The study population: Inclusion criteria: Kidney transplant recipients underwent immunosuppresion regimen consists of Tacrolimus, Mycophenolate and Prednisolone who are clinically suspicious or definitely diagnosed with AMR (Antibody-mediated acute rejection). Sample size: 10 patients in each group. b-Interventions: Patients will receive treatment regimens including plasmapheresis and IVIg or the plasmapheresis plus IVIg plus 4 weekly doses of 375mg/m2 Rituximab or plasmapheresis plus IVIg plus 2 weekly doses of 375mg/m2 Rituximab. The first two regimens are the regimens currently being used in our transplantation centers. The third group is the group will undergo the intervention. c- Time of intervention: When the patient is clinically suspicious or definitely diagnosed with AMR. d- The outcomes studied: Clinical condition of the patients, serum creatinine, urine output, complete blood count and serum LDH (Lactate dehydrogenase) will be compared on a daily basis during hospitalization and then monthly to the end of 3-month follow-up period among 3 groups. Patient and graft survival will be compared as a secondary outcome.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201508103043N10
Registration date:2016-08-17, 1395/05/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-08-17, 1395/05/27
Registrant information
Name
Simin Dashti-Khavidaki
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6695 4709
Email address
dashtis@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2016-02-20, 1394/12/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing plasmapheresis+IVIg vs plasmapheresis+IVIg+ High dose rituximab vs plasmapheresis+IVIg+ Low dose rituximab on the management of antibody-mediated rejection in kidney transplant recipients
Public title
Comparing high dose and low dose Rituximab in the treatment of rejection in kidney transplant recipients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. Kidney transplant recipients recieve immunosuppression regimen including Thymoglobulin+Tacrolimus+Mycophenolate+ Prednisolone
2. Strong clinical suspicious of antibody-mediated acute rejection (AMR) (sudden impairment in function of the graft including anuria and increasing serum creatinine after a few days of having functional kidney) or definite diagnosis of AMR (morphologic and immunopathologic evidences of AMR in a biopsy specimen of the graft) or measuring serum DSA (Donor-specific antibody) levels.
Exclusion criteria:
1. The patient's preference not to proceed the treatment
2. Evidence of definite diagnosis other than AMR in Pathologic report
3. Serious side effects associated to the medications used in this trial
Age
From 14 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, 16 Azar St., Enghelab St, Tehran, Iran
City
Tehran
Postal code
Approval date
2016-02-23, 1394/12/04
Ethics committee reference number
IR.TUMS.REC.1394.2059
Health conditions studied
1
Description of health condition studied
Antibody-mediated rejection in kidney transplant recipients
ICD-10 code
Z94.0
ICD-10 code description
Kidney transplant status
Primary outcomes
1
Description
Recipient serum Creatinine
Timepoint
Daily during hospitalization, then weekly until the end of the first month after transplant, then monthly until the end of the third month after transplat
Method of measurement
Blood samples in laboratories in milligrams / deciliter (jaffe technique)
2
Description
Recipient urine output
Timepoint
Before transplantation and daily during hospitalization
Method of measurement
Graduated container in ml/day
Secondary outcomes
1
Description
Complete blood count
Timepoint
Daily during hospitalization
Method of measurement
Laboratory
2
Description
Srum lactate dehydrogenase
Timepoint
Twice weekly during hospitalization
Method of measurement
Laboratory
3
Description
3-month Graft survival
Timepoint
Monthly follow-up
Method of measurement
Going back of recipient to dialysis
4
Description
3-month patient survival
Timepoint
Monthly follow-up
Method of measurement
Patient death or live
Intervention groups
1
Description
Control group (regimen currently being used in some Iranian transplant centers): Plasmapheresis+ IVIg+ high-dose Rituximab: Patients will receive 100mg/kg Of IVIg after each plasmapheresis session. 4 doses of Rituximab (375mg/m2) will be administered on weekly basis. The next plasmapheresis session after administration of Rituximab will be 48-72 hours later.
Category
Treatment - Drugs
2
Description
Intervention group: Plasmapheresis+ IVIg+ low-dose Rituximab: IVIg (100mg/kg) will be infused after each plasmaoheresis session.2 doses of Rituximab (375mg/m2) will be administered on a weekly basis. The next plasmapheresis session after Rituximab administration will be 48-72 hours later
Category
Treatment - Drugs
3
Description
Control group (regimen currently being used in some Iranian transplant centers): IVIg+ plasmapheresis. The patients will receive 300-400mg/kg of IVIg after each plasmapheresis session to the total cumulative dose of 2g/kg