Efficacy and security of low toxicity immunosuppressive regimen using basiliximab, mycophenolate mofetil, neoral or tacrolimus and corticosteroids versus full doses of neoral, thymoglobulin, azathioprine and corticosteroids

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN87678078

Enrollment

240

Registered

2007-01-04

Start date

1999-10-27

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Kidney transplant Urological and Genital Diseases Kidney transplant

Interventions

Group one: thymoglobulin (1 to 1.5 mg/k/day for seven days), CsA (8 mg/k/day

levels: 175 to 225 ng/ml), azathioprine (1.5 mg/k/day) and corticosteroids Group two: basiliximab (20 mg days zero and four), CsA (4 mg/k/day, levels: 125 to 175 ng/ml), MMF (2 g/day) and corticostero

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged over 18 years 2. Accepted informed consent 3. Primary kidney allograft 4. Cadaveric donor

Exclusion criteria

Exclusion criteria: 1. Panel Reactive Antibody (PRA) over 50% 2. History of malignancy 3. History of infection 4. Previous treatment with polyclonal antibodies or basiliximab

Design outcomes

Primary

Measure	Time frame
To determine renal function evaluated by calculated creatinine clearance at 6 and 12 months.	—

Secondary

Measure	Time frame
To assess acute rejection rate at 6 and 12 months, patient and graft survival rate at 12 months.	—

Countries

Spain

Outcome results

None listed

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