Condition category
Injury, Occupational Diseases, Poisoning
Date applied
09/06/2010
Date assigned
18/06/2010
Last edited
13/09/2011
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 Mara Medeiros

ORCID ID

Contact details

Dr. Marquez 162
Colonia Doctores
Mexico DF
06720
Mexico
+52 (0)555 52289917
medeiro.mara@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HIM/2009/015

Study information

Scientific title

Aldosterone blockade in children with chronic allograft nephropathy: A prospective randomized controlled trial with patient blinding

Acronym

ABCWCAN (Efecto del Bloqueo de Aldosterona en la Nefropatía Crónica en Niños con Trasplante Renal)

Study hypothesis

Eplerenone prevents the progression of chronic allograft nephropathy in children

Ethics approval

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)

Study design

Prospective single blind randomized controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

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

Phase

Phase IV

Drug names

Eplerenone

Primary outcome measures

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 trial start date

01/06/2009

Overall trial end date

30/06/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

62

Participant 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

Recruitment start date

01/06/2009

Recruitment end date

30/06/2011

Locations

Countries of recruitment

Mexico

Trial participating centre

Dr. Marquez 162
Mexico DF
06720
Mexico

Sponsor information

Organisation

Sectorial Fund for Health Research (Fondo Sectorial de Investigación en Salud) (Mexico)

Sponsor details

Av. Insurgentes Sur no. 1582
6º Piso
Dirección de Investigación Aplicada
DADCYA
Col. Crédito Constructor
Mexico DF
03940
Mexico

Sponsor type

Government

Website

http://www.conacyt.mx/

Funders

Funder type

Government

Funder name

National Board of Science and Technology (Consejo Nacional de Ciencia y Tecnología) (Mexico) - Health Sector Fund 2008 (ref: 000000000087381)

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

Publication citations

Additional files

Editorial Notes