Comparison of de novo sirolimus plus tacrolimus with tacrolimus plus mycofenolic acid in renal transplantation

Comparison of de novo sirolimus plus tacrolimus with tacrolimus plus mycofenolic acid in renal transplantation: a randomized clinical trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN19991928

Enrollment

120

Registered

2017-06-15

Start date

2016-10-01

Completion date

Unknown

Last updated

2020-02-03

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

Conditions

Kidney transplantation Urological and Genital Diseases

Interventions

Participants are randomised by block randomisation to group A or B: Group A: Thymoglobulin 3mg/kg divided in 3-4 days Myfortic (mycophenolic acid) 360

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. First transplant 2. Cadaveric and living unrelated donor (age of cadaveric donor<50 years) 3. PRA negative (cytotoxicity) 4. Pretransplant anti-HLA negative (solid phase ELISA) 5. BMI <30 6. Age 18-65

Exclusion criteria

Exclusion criteria: 1. DGF (need for dialysis in first week) 2. SGF (serum creatinine > 3 mg/dl in day 3)

Design outcomes

Primary

Measure	Time frame
1. Estimation of glomerular filtration rate (GFR) based on Modification of Diet in Renal Disease (MDRD) at months 3, 6 and 12 2. Biopsy proven acute rejection (BPAR) (indication for biopsy when creatinine rise > 0.3 mg/dl for continuous 2 days) at months 3 and 12	—

Secondary

Measure	Time frame
1. Incidence of borderline changes, subclinical acute cellular rejection and subclinical antibody mediated rejection (ABMR), measured by protocol biopsy at month 4 2. Incidence of new-onset diabetes after transplantation (NODAT) at 3, 6, 12 months 3. Incidence of donor specific anti-HLA antibodies (DSA), measured using solid phase ELISA at 4 and 12 months 4. Incidence of hypertension at 3, 6 and 12 months 5. Incidence of hyperlipidemia (total cholesterol, LDL-C, HDL-C and TG) at months 3, 6 and 12 6. Incidence of CMV viremia ( >2000 copies/ml) and CMV disease (fever, leukopenia or organ involvement with CMV DNAemia >2000 copies/ml), measured using CMV viral load every month for first 3 months and then every 3 months for 1 year 7. Incidence of BK viremia ( >10000 copy/ml blood) and BK associated nephropathy, measured using BK virus plasma PCR every month for first 3 months then every 3 months	—

Measure

Time frame

1. Incidence of borderline changes, subclinical acute cellular rejection and subclinical antibody mediated rejection (ABMR), measured by protocol biopsy at month 4 2. Incidence of new-onset diabetes after transplantation (NODAT) at 3, 6, 12 months 3. Incidence of donor specific anti-HLA antibodies (DSA), measured using solid phase ELISA at 4 and 12 months 4. Incidence of hypertension at 3, 6 and 12 months 5. Incidence of hyperlipidemia (total cholesterol, LDL-C, HDL-C and TG) at months 3, 6 and 12 6. Incidence of CMV viremia ( >2000 copies/ml) and CMV disease (fever, leukopenia or organ involvement with CMV DNAemia >2000 copies/ml), measured using CMV viral load every month for first 3 months and then every 3 months for 1 year 7. Incidence of BK viremia ( >10000 copy/ml blood) and BK associated nephropathy, measured using BK virus plasma PCR every month for first 3 months then every 3 months

—

Countries

Iran

Outcome results

None listed

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