Safety and efficacy of Anti-Thymocyte Globulin (Zist Kowsar Pharmaceutical Company) in comparison with Anti-Thymocyte Globulin (Genzyme) for immunosuppressive induction therapy in adults with renal transplantatio

Phase 3

Recruiting

• Conditions: Renal transplantation.; Kidney transplant status; Z94.0

• Registration Number: IRCT20100127003200N6
• Lead Sponsor: Kowsar Biotechnology company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 7 February 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 129

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.