Aldosterone blockade in children with chronic allograft nephropathy

Completed

• Conditions: Chronic allograft nephropathy; Injury, Occupational Diseases, Poisoning; Kidney transplant failure and rejection

• Registration Number: ISRCTN19419571
• Lead Sponsor: Sectorial Fund for Health Research (Fondo Sectorial de Investigación en Salud) (Mexico)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-18
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 62

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Change in glomerular filtration rate at 24 months

Secondary Outcome Measures

Name	Time	Method
1. Acute rejection episodes in 24 months<br>2. Graft and patient loss<br>3. Adverse effects<br>4. Change in proteinuria<br>5. Change in urinaty nitrates excretion<br>6. Change in plasma levels of TGF-beta, aldosterone