The effect of two different drug protocols on the kidney transplant patients immune system

Compare changes two subsets of regulatory T cells (Treg) and gene expression of Foxp3, ROR?T, T-bet and GATA-3 in kidney transplant patients under two different treatment protocols

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT2016062528620N1

Enrollment

Registered

2017-01-20

Start date

2016-06-04

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. Kidney transplant status

Interventions

Intervention 1: Group A:patients take tacrolimus with Mycophenolic acid.give them 0.1 mg / kg Tacrolimus for 90 days to achieve 8-12 ng/ml plasma levels. then for achieveing 5-8ng/ml plasma level wil

Treatment - Drugs

Group A:patients take tacrolimus with Mycophenolic acid.give them 0.1 mg / kg Tacrolimus for 90 days to achieve 8-12 ng/ml plasma levels. then for achieveing 5-8ng/ml plasma level will adjust the dos

Group B: pateints take tacrolimus with sirolimus. give them 0.8 mg/kg tacrolimus for 6 months to achieve6-7 ng/ml plasma levels and then4-5 ng/ml the plasma level will adjust the dose in the next 6

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1.Patients who receive a transplant for the first time; 2.live or unrelated cadavric donor (under 50 years); 3.All transplant recipients in terms of PRA (Panel reactive antibody) are negative; 4. Patients anti HLA antibody should be negative; 5. BMI <30; 6.Transplant recipients age: 65-18 years old; 7. The possibility of underlying diseases and infections in patients is low. Exclusion criteria: 1. If the patient does not want to cooperate in the study; 2. Patients suffering from the nephrotoxicity.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Regulatory T CD4+CD25+Foxp3+ cell. Timepoint: Before intervention and 4 months after intervention. Method of measurement: Flow cytometry technique.;Regulatory T CD8+CD28- cell. Timepoint: Before intervention and 4 months after intervention. Method of measurement: Flow cytometry technique.;Added at 2017-03-05: type 1 myeloid dendritic cells. Timepoint: Added at 2017-03-05: Before intervention and 4 months after. Method of measurement: Added at 2017-03-05: Flow cytometry technique.;Added at 2017-03-05: plasmacytoid dendritic cells. Timepoint: Added at 2017-03-05: Before intervention and 4 months after. Method of measurement: Added at 2017-03-05: Flow cytometry technique.;Added at 2017-03-05: T helper 17 cells. Timepoint: Added at 2017-03-05: Before intervention and 4 months after. Method of measurement: Added at 2017-03-05: Flow cytometry technique.;Added at 2017-03-05: T helper 1 cells. Timepoint: Added at 2017-03-05: Before intervention and 4 months after. Method of measurement: Added at 2017-03-05: Flow cytometry technique.;Added at 2017-03-05: T helper2 cells. Timepoint: Added at 2017-03-05: Before intervention and 4 months after. Method of measurement: Added at 2017-03-05: Flow cytometry technique.	—

Measure

Time frame

Regulatory T CD4+CD25+Foxp3+ cell. Timepoint: Before intervention and 4 months after intervention. Method of measurement: Flow cytometry technique.;Regulatory T CD8+CD28- cell. Timepoint: Before intervention and 4 months after intervention. Method of measurement: Flow cytometry technique.;Added at 2017-03-05: type 1 myeloid dendritic cells. Timepoint: Added at 2017-03-05: Before intervention and 4 months after. Method of measurement: Added at 2017-03-05: Flow cytometry technique.;Added at 2017-03-05: plasmacytoid dendritic cells. Timepoint: Added at 2017-03-05: Before intervention and 4 months after. Method of measurement: Added at 2017-03-05: Flow cytometry technique.;Added at 2017-03-05: T helper 17 cells. Timepoint: Added at 2017-03-05: Before intervention and 4 months after. Method of measurement: Added at 2017-03-05: Flow cytometry technique.;Added at 2017-03-05: T helper 1 cells. Timepoint: Added at 2017-03-05: Before intervention and 4 months after. Method of measurement: Added at 2017-03-05: Flow cytometry technique.;Added at 2017-03-05: T helper2 cells. Timepoint: Added at 2017-03-05: Before intervention and 4 months after. Method of measurement: Added at 2017-03-05: Flow cytometry technique.

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Secondary

Measure	Time frame
Foxp3 gene. Timepoint: Before intervention and 4 months after intervention. Method of measurement: RT-PCR Technique.;T-bet gene. Timepoint: Before intervention and 4 months after intervention. Method of measurement: RT-PCR Technique.;ROR?T gene. Timepoint: Before intervention and 4 months after intervention. Method of measurement: RT-PCR Technique.;GATA3 gene. Timepoint: Before intervention and 4 months after intervention. Method of measurement: RT-PCR Technique.;Added at 2017-03-05: Interferon gamma (IFN?). Timepoint: Added at 2017-03-05: Before intervention and 4 months after intervention. Method of measurement: Added at 2017-03-05: elisa technique.;Added at 2017-03-05: Interleukin-4. Timepoint: Added at 2017-03-05: Before intervention and 4 months after intervention. Method of measurement: Added at 2017-03-05: elisa technique.;Added at 2017-03-05: Interleukin-17A (IL-17A). Timepoint: Added at 2017-03-05: Before intervention and 4 months after intervention. Method of measurement: Added at 2017-03-05: elisa technique.;Added at 2017-03-05: ILT4 gene. Timepoint: Added at 2017-03-05: Before intervention and 4 months after. Method of measurement: Added at 2017-03-05: RT-PCR Technique.;Added at 2017-03-05: ILT3 gene. Timepoint: Added at 2017-03-05: Before intervention and 4 months after intervention. Method of measurement: Added at 2017-03-05: RT-PCR Technique.;Added at: type 2 myeloid dendritic cells. Timepoint: Added at: Before intervention and 4 months after. Method of measurement: Added at: Flow cytometry technique.	—

Measure

Time frame

Foxp3 gene. Timepoint: Before intervention and 4 months after intervention. Method of measurement: RT-PCR Technique.;T-bet gene. Timepoint: Before intervention and 4 months after intervention. Method of measurement: RT-PCR Technique.;ROR?T gene. Timepoint: Before intervention and 4 months after intervention. Method of measurement: RT-PCR Technique.;GATA3 gene. Timepoint: Before intervention and 4 months after intervention. Method of measurement: RT-PCR Technique.;Added at 2017-03-05: Interferon gamma (IFN?). Timepoint: Added at 2017-03-05: Before intervention and 4 months after intervention. Method of measurement: Added at 2017-03-05: elisa technique.;Added at 2017-03-05: Interleukin-4. Timepoint: Added at 2017-03-05: Before intervention and 4 months after intervention. Method of measurement: Added at 2017-03-05: elisa technique.;Added at 2017-03-05: Interleukin-17A (IL-17A). Timepoint: Added at 2017-03-05: Before intervention and 4 months after intervention. Method of measurement: Added at 2017-03-05: elisa technique.;Added at 2017-03-05: ILT4 gene. Timepoint: Added at 2017-03-05: Before intervention and 4 months after. Method of measurement: Added at 2017-03-05: RT-PCR Technique.;Added at 2017-03-05: ILT3 gene. Timepoint: Added at 2017-03-05: Before intervention and 4 months after intervention. Method of measurement: Added at 2017-03-05: RT-PCR Technique.;Added at: type 2 myeloid dendritic cells. Timepoint: Added at: Before intervention and 4 months after. Method of measurement: Added at: Flow cytometry technique.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactSaeedeh Jamali

Tehran University of Medical Sciences

jamali.sa71@gmail.com; sjamali@razi.tums.ac.ir+98 21 8895 3009

Outcome results

None listed

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