The effect of low dose Daclizumab on the risk of rejection in renal allograft recipients

The effect of adding low dose Daclizumab to renal transplantation standard protocol on reduction the risk of kidney rejection in renal allograft recipients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT138802021836N1

Enrollment

120

Registered

2010-04-06

Start date

2008-04-01

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

kidney transplant rejection. Kidney transplant failure and rejection

Interventions

Intervention 1: Intervention group: Daclizumab 1mg/kg at the day of surgery and after 14 days with Cyclosporine (starts with 5-8mg/kg adjusted according to its serum level, mycophenolate mofetil (2 gr

Treatment - Drugs

Intervention group: Daclizumab 1mg/kg at the day of surgery and after 14 days with Cyclosporine (starts with 5-8mg/kg adjusted according to its serum level, mycophenolate mofetil (2 gr daily) and pred

control group: Cyclosporine (starts with 5-8mg/kg adjusted according to its serum level, mycophenolate mofetil (2 gr daily) and prednisolone (it starts with 1 mg/kg then it was tapered) for the whole

Eligibility

Sex/Gender

All

Age

10 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Candidate for renal transplantation from living donor that sign the informed consent Exclusion criteria: hypersensitivity to Daclizumab or any component of the formulation, positive past history of renal transplantation, inability to receive the second dose

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Serum creatinine level. Timepoint: 0, 1, 2, 3, 4, 5, and 6 months after surgery and when symptoms suggested rejection. Method of measurement: serum creatinin measurement.;Histopathologic change suggested rejection. Timepoint: when sing and symptom, creatinine, or kidney sonography findings are susspected to graft rejection. Method of measurement: renal biopsy and pathologic evaluation.;Sonographic finding of graft rejection. Timepoint: when sing and symptom, creatinine, or kidney sonography findings are susspected to graft rejection. Method of measurement: sonography of allograft kidney.	—

Measure

Time frame

Serum creatinine level. Timepoint: 0, 1, 2, 3, 4, 5, and 6 months after surgery and when symptoms suggested rejection. Method of measurement: serum creatinin measurement.;Histopathologic change suggested rejection. Timepoint: when sing and symptom, creatinine, or kidney sonography findings are susspected to graft rejection. Method of measurement: renal biopsy and pathologic evaluation.;Sonographic finding of graft rejection. Timepoint: when sing and symptom, creatinine, or kidney sonography findings are susspected to graft rejection. Method of measurement: sonography of allograft kidney.

—

Secondary

Measure	Time frame
Time to allograft rejection. Timepoint: For 6 months after surgery. Method of measurement: days or months to rejection.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyed Mojtaba Sohrevardi

Kerman University of Medical Sciences

smsohrevardi@yahoo.com , smsohrevardi@kmu.ac.ir+98 34 1320 5001

Outcome results

None listed

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