Aldosterone blockade in children with chronic allograft nephropathy
| ISRCTN | ISRCTN19419571 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN19419571 |
| Secondary identifying numbers | HIM/2009/015 |
- Submission date
- 09/06/2010
- Registration date
- 18/06/2010
- Last edited
- 13/09/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Mara Medeiros
Scientific
Scientific
Dr. Marquez 162
Colonia Doctores
Mexico DF
06720
Mexico
| Phone | +52 (0)555 52289917 |
|---|---|
| medeiro.mara@gmail.com |
Study information
| Study design | Prospective single blind randomized controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet |
| Scientific title | Aldosterone blockade in children with chronic allograft nephropathy: A prospective randomized controlled trial with patient blinding |
| Study acronym | ABCWCAN (Efecto del Bloqueo de Aldosterona en la Nefropatía Crónica en Niños con Trasplante Renal) |
| Study objectives | Eplerenone prevents the progression of chronic allograft nephropathy in children |
| Ethics approval(s) | The local research ethics committee (Comisión de Etica Hospital Infantil de México Federico Gómez) approved on the 16th f June 2009 (ref: HIM/2009/015) |
| Health condition(s) or problem(s) studied | Chronic allograft nephropathy |
| Intervention | Patients are randomized to receive Eplerenone to induce aldosterone blockade or a placebo. Visits scheduled at baseline, 1, 2, 4, 8, 12, 24 weeks and every three months afterwards to complete 2 years of follow-up. A complete clinical examination is performed and blood sample is drawn for complete blood cell count, serum levels of creatinine, electrolytes, transaminases, cholesterol, tryglicerides. 24h urine collection for proteinuria and urine nitrates. Aldosterone and TGFb plasma levels will be measured every six months. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Eplerenone |
| Primary outcome measure | 1. Change in glomerular filtration rate at 24 months |
| Secondary outcome measures | 1. Acute rejection episodes in 24 months 2. Graft and patient loss 3. Adverse effects 4. Change in proteinuria 5. Change in urinaty nitrates excretion 6. Change in plasma levels of TGF-beta, aldosterone |
| Overall study start date | 01/06/2009 |
| Completion date | 30/06/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Years |
| Upper age limit | 17 Years |
| Sex | Both |
| Target number of participants | 62 |
| Key inclusion criteria | 1. Patients aged 6 to 17 years within at least six months of receiving renal transplant 2. Patients with stable graft function defined as serum creatinine variation in the previous three months lower than 0.2 mg/dL 3. Chronic allograft nephropathy diagnosed by renal biopsy and Banff criteria 4. No evidence of acute rejection in the previous three months before enrolment 5. Glomerular filtration rate > 40 mL/min ( Schwartz formula). 6. Serum potassium ≤ 5 mEq/L 7. Informed consent/assent properly signed |
| Key exclusion criteria | 1. Acute graft rejection in the three months prior to enrolment 2. Serum creatinine variation in the previous three months > 0.2 mg/dL 3. Plasma Serum potassium > 5 mEq/L 4. Arterial hipotension 5. Patients receiving clarytromicin, calcium antagonists, itraconazol, fluconazol, erythromycin 6. Use of eplerenone 4 prior to enrolment |
| Date of first enrolment | 01/06/2009 |
| Date of final enrolment | 30/06/2011 |
Locations
Countries of recruitment
- Mexico
Study participating centre
Dr. Marquez 162
Mexico DF
06720
Mexico
06720
Mexico
Sponsor information
Sectorial Fund for Health Research (Fondo Sectorial de Investigación en Salud) (Mexico)
Government
Government
Av. Insurgentes Sur no. 1582, 6º Piso
Dirección de Investigación Aplicada, DADCYA
Col. Crédito Constructor
Mexico DF
03940
Mexico
| Website | http://www.conacyt.mx/ |
|---|
Funders
Funder type
Government
National Board of Science and Technology (Consejo Nacional de Ciencia y Tecnología) (Mexico) - Health Sector Fund 2008 (ref: 000000000087381)
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 |
