Chronic allograft nephropathy Injury, Occupational Diseases, Poisoning Kidney transplant failure and rejection
Conditions
Interventions
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
Sponsors
Sectorial Fund for Health Research (Fondo Sectorial de Investigación en Salud) (Mexico)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in glomerular filtration rate at 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Mexico
Outcome results
None listed