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
| ISRCTN | ISRCTN87678078 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87678078 |
| Protocol serial number | N/A |
| Sponsor | Hospital Universitario de Canarias (Spain) |
| Funder | Fundation Rafael Clavijo, Research Unit, Hospital Universitario de Canarias (Spain) |
- Submission date
- 12/09/2006
- Registration date
- 04/01/2007
- Last edited
- 04/01/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Domingo Hernandez
Scientific
Scientific
Nephrology Service
Hospital Universitario de Canarias
Ofra s/n La Laguna
Tenerife
38320
Spain
| Phone | +34 922 678 545 |
|---|---|
| domingohernandez@gmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective, randomised, open-label, single centre, three parallel therapeutic armed trial. |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | Immuno99 |
| Study objectives | To compare efficacy and security of low toxicity immunosuppressive regimen using basiliximab, mycophenolate mofetil (MMF), neoral (cyclosporin A [CsA]) or tacrolimus and corticosteroids versus full doses of neoral, thymoglobulin, azathioprine and corticosteroids. |
| Ethics approval(s) | Approval received in May 1999 from two sources: 1. The Ethics Committee of the University Hospital of the Canary Islands (ref: Inmuno/99) 2. Agencia Española del Medicamento from Spanish Ministry of Health (ref: 99-0296) |
| Health condition(s) or problem(s) studied | Kidney transplant |
| Intervention | 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 corticosteroids Group three: basiliximab (20 mg days zero and four), tacrolimus (0.1 mg/k/day, levels: 8 to 12 ng/ml), MMF (2 g/day) and corticosteroids |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Basiliximab, mycophenolate mofetil (MMF), neoral (cyclosporin A [CsA]), tacrolimus, corticosteroids, thymoglobulin, azathioprine. |
| Primary outcome measure(s) |
To determine renal function evaluated by calculated creatinine clearance at 6 and 12 months. |
| Key secondary outcome measure(s) |
To assess acute rejection rate at 6 and 12 months, patient and graft survival rate at 12 months. |
| Completion date | 21/03/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 240 |
| Key inclusion criteria | 1. Aged over 18 years 2. Accepted informed consent 3. Primary kidney allograft 4. Cadaveric donor |
| Key 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 |
| Date of first enrolment | 27/10/1999 |
| Date of final enrolment | 21/03/2004 |
Locations
Countries of recruitment
- Spain
Study participating centre
Nephrology Service
Tenerife
38320
Spain
38320
Spain
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 27/09/2007 | Yes | No |
