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Clinical Trials/ISRCTN19419571
ISRCTN19419571
Completed
Not Applicable

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

Sectorial Fund for Health Research (Fondo Sectorial de Investigación en Salud) (Mexico)0 sites62 target enrollmentJune 18, 2010
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Sectorial Fund for Health Research (Fondo Sectorial de Investigación en Salud) (Mexico)
Enrollment
62
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 18, 2010
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional
Sex
All

Investigators

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

Eligibility 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

  • •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

Outcomes

Primary Outcomes

Not specified

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