Renal transplantation. Kidney transplant status
Conditions
Interventions
Intervention 1: Intervention group 1: 1- TGlobulin (Kowsar biotech Co.): 1-1.5 mg/kg/d for 4 days (Total dose of 3-7 mg/kg for each patient) 2- Cellcept 1gr/stat then 1gr/BD or Myfortic 720 mg/stat t
Sponsors
Kowsar Biotechnology company
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age >18 years (donor age >= 5) for recipient ability and willingness to sign the informed consent Reception of kidney from cadaver OR second graft (already rejected a kidney more than 6-12 month ago) OR indication for receiving the investigated drug
Exclusion criteria
Exclusion criteria: Positive history of polyclonal Anti-T-Cell therapy Known allergy to Rabbit proteins Positive history of malignancy in 2 years( excluding stem cell , squamous cell, bladder malignancies and asymptomatic invasive papillary renal cell cancer with less than 5 cm size) Pregnancy Lactating mother Willingness to pregnancy and not using a safe contraceptive method Positive serology for: HTLV, HIV or HBV
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Any adverse reaction. Timepoint: Any time after intervention. Method of measurement: Clinical or laboratory data.;Graft rejection. Timepoint: After 6 months. Method of measurement: Investigator documentation during follow-up.;Patient death/survival. Timepoint: After graft to end of follow up. Method of measurement: Investigator documentation during follow-up.;Graft loss. Timepoint: After graft to end of follow up. Method of measurement: Investigator documentation during follow-up.;Incidence of infection (especially CMV). Timepoint: After graft to end of follow up. Method of measurement: Periodic Lab data during follow up.;Serious adverse events. Timepoint: After graft to end of follow up. Method of measurement: Investigator documentation during follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Delayed graft function (DGF). Timepoint: During the first 7 days after transplantation. Method of measurement: Having dialysis during the first 7 days after transplantation.;Hospitalization time after transplantation. Timepoint: Graft to discharge time. Method of measurement: Hospital records.;T-cell lymphocyte count. Timepoint: Before and after drug injection. Method of measurement: Lab data: Complete blood count. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMehdi Behdani
Pasture Institute of Iran
Outcome results
None listed