Comparison of cyclosporine and tacrolimus in two immunosuppressive drug regimen in patients undergoing kidney transplantation

Comparison of two different drug regimen containing tacrolimus and cyclosporine on graft survival and the survival rate of patients as immunosuppressive regimens in kidney transplantation

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT201105166500N1

Enrollment

200

Registered

2011-06-19

Start date

2011-05-03

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

survival of transplanted kidney. Kidney transplant failure and rejection

Interventions

Intervention 1: Group B: tacrolimus: 1 mg twice a day immediately after transplantation until a year. Micofenolate meftile: the night before the transplant, 1 g, twice a day until a year. Prednisolone

Treatment - Drugs

Group B: tacrolimus: 1 mg twice a day immediately after transplantation until a year. Micofenolate meftile: the night before the transplant, 1 g, twice a day until a year. Prednisolone:at first, 3 pul

Group A: Cyclosporine: after transplantation, 12 mg/kg/day, gradually reduced to half the dose in the first month and then a dose of 5 mgr/kg/day, until one year. Micofenolate meftile: the night befo

Eligibility

Sex/Gender

All

Age

16 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: all patients with chronic renal failure aged 16 to 65 who were undergoing kidney transplantation and immunosuppressive therapy for graft. Exclusion criteria: patients with other diseases such as cancer; intraoperative surgical complications in renal transplantation in grafts; graft loss due to vascular complications created from the graft surgery; death (due to other causes than rejection); switching immunosuppressive treatment regimen for any reason.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Acute rejection of kidney transplantation. Timepoint: 1 , 3 , 6 , 9 , 12 months after transplantation. Method of measurement: clinical findings, sonographic findings, findings of DTPA scan, biopsy.;Coronic rejection of kidney transplantation. Timepoint: 1 , 3 , 6 , 9 , 12 months after transplantation. Method of measurement: Gradual increase in plasma creatinine and the need for dialysis in patient that has not required dialysis. based on clinical symptoms, renal biopsy diagnosed increase of creatinine gradually.	—

Measure

Time frame

Acute rejection of kidney transplantation. Timepoint: 1 , 3 , 6 , 9 , 12 months after transplantation. Method of measurement: clinical findings, sonographic findings, findings of DTPA scan, biopsy.;Coronic rejection of kidney transplantation. Timepoint: 1 , 3 , 6 , 9 , 12 months after transplantation. Method of measurement: Gradual increase in plasma creatinine and the need for dialysis in patient that has not required dialysis. based on clinical symptoms, renal biopsy diagnosed increase of creatinine gradually.

—

Secondary

Measure	Time frame
GFR. Timepoint: 1 , 3 , 6 , 9 , 12 months after transplantation. Method of measurement: with GFR formula.;Drugs side effect. Timepoint: 1 , 3 , 6 , 9 , 12 months after transplantation. Method of measurement: alergy, intolerance, blood presure increase.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Abdoreza Mahrui

Kermanshah University of Medical Scienes and Health Services

abmahrooei@kums.ac.ir+98 83 1427 6301

Outcome results

None listed

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