Condition category
Urological and Genital Diseases
Date applied
12/09/2006
Date assigned
04/01/2007
Last edited
04/01/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Domingo Hernandez

ORCID ID

Contact details

Nephrology Service
Hospital Universitario de Canarias
Ofra s/n La Laguna
Tenerife
38320
Spain
+34 922 678 545
domingohernandez@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

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

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)

Study design

Prospective, randomised, open-label, single centre, three parallel therapeutic armed trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Phase

Not Specified

Drug names

Basiliximab, mycophenolate mofetil (MMF), neoral (cyclosporin A [CsA]), tacrolimus, corticosteroids, thymoglobulin, azathioprine.

Primary outcome measures

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 trial start date

27/10/1999

Overall trial end date

21/03/2004

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

240

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

Trial participating centre

Nephrology Service
Tenerife
38320
Spain

Sponsor information

Organisation

Hospital Universitario de Canarias (Spain)

Sponsor details

Fundation Rafael Clavijo
Research Unit
Ofra s/n La Laguna
Tenerife
38320
Spain
+34 922 678 545
domingohernandez@gmail.com

Sponsor type

Hospital/treatment centre

Website

http://www.hecit.es

Funders

Funder type

University/education

Funder name

Fundation Rafael Clavijo, Research Unit, Hospital Universitario de Canarias (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in: http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=17893603

Publication citations

  1. Results

    Hernández D, Miquel R, Porrini E, Fernández A, González-Posada JM, Hortal L, Checa MD, Rodríguez A, García JJ, Rufino M, Torres A, Randomized controlled study comparing reduced calcineurin inhibitors exposure versus standard cyclosporine-based immunosuppression., Transplantation, 2007, 84, 6, 706-714, doi: 10.1097/01.tp.0000282872.17024.b7.

Additional files

Editorial Notes