Status:
WITHDRAWN
Allopurinol for Renal Transplant Associated Hypertension in Children
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsors:
Baylor University
Conditions:
Hypertension
Renal Transplant
Eligibility:
All Genders
6-18 years
Phase:
PHASE1
PHASE2
Brief Summary
To test the hypothesis that lowering serum uric acid will ameliorate hypertension in children after renal transplantation.
Detailed Description
The study will be a double-blind, placebo-controlled, crossover trial. We will recruit 25 children between the ages of 6 and 18 years, from the pediatric renal transplant program at Texas Children's H...
Eligibility Criteria
Inclusion
- Males or females 6 to 18 years in age. Post-menarche females must have a negative urine pregnancy test.
- Renal transplant recipient taking cyclosporin.
- Weight greater than 20kg
- Parental or guardian consent and child subject assent (if appropriate)
- SBP or DBP greater than 95th percentile for age, gender and height
Exclusion
- Severe or poorly controlled hypertension as defined by SBP or DBP more than 20mmHg \>95th percentile for age, gender and height on active therapy, on 2 or more antihypertensive medications or a history of hypertensive encephalopathy
- Taking azathioprine or another nucleoside analogue medication
- Currently receiving ACE-I or ARB medications
- Laboratory abnormalities that indicate clinically significant hematologic, hepatobiliary or renal disease: Schwartz Formula GFR less than 60ml/min/1.73m2 ALT/SGPT greater than 2 times the upper limit of normal\* Hemoglobin less than 9 gm/dl WBC less than 3.000/mm3 Platelet count less than 100,000/mm3 \*age-adjusted normal range, TCH laboratory
- A history of cardiomyopathy, clinically significant structural heart disease or atrioventricular conduction disturbance, sick sinus syndrome, clinically significant cardiac arrhythmia or symptoms of congestive heart failure
- Pregnant or lactating females
- Any other investigational drug use within 30 days of enrollment
- Parents/guardians or subjects who, in the opinion of the investigator, may be non-compliant with the study procedures.
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00288171
Start Date
February 1 2006
End Date
June 1 2008
Last Update
September 13 2017
Active Locations (1)
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1
Texas Children's Hospital
Houston, Texas, United States, 77030