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 |
| Secondary identifying numbers | N/A |
- 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
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
| Study design | Prospective, randomised, open-label, single centre, three parallel therapeutic armed trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | Immuno99 |
| Study hypothesis | 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) |
| Condition | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Basiliximab, mycophenolate mofetil (MMF), neoral (cyclosporin A [CsA]), tacrolimus, corticosteroids, thymoglobulin, azathioprine. |
| Primary outcome measure | To determine renal function evaluated by calculated creatinine clearance at 6 and 12 months. |
| Secondary outcome measures | To assess acute rejection rate at 6 and 12 months, patient and graft survival rate at 12 months. |
| Overall study start date | 27/10/1999 |
| Overall study end date | 21/03/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 240 |
| Participant inclusion criteria | 1. Aged over 18 years 2. Accepted informed consent 3. Primary kidney allograft 4. Cadaveric donor |
| Participant 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 |
| Recruitment start date | 27/10/1999 |
| Recruitment end date | 21/03/2004 |
Locations
Countries of recruitment
- Spain
Study participating centre
Nephrology Service
Tenerife
38320
Spain
38320
Spain
Sponsor information
Hospital Universitario de Canarias (Spain)
Hospital/treatment centre
Hospital/treatment centre
Fundation Rafael Clavijo
Research Unit
Ofra s/n La Laguna
Tenerife
38320
Spain
| Phone | +34 922 678 545 |
|---|---|
| domingohernandez@gmail.com | |
| Website | http://www.hecit.es |
"ROR" |
https://ror.org/05qndj312 |
Funders
Funder type
University/education
Fundation Rafael Clavijo, Research Unit, Hospital Universitario de Canarias (Spain)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
