Allopurinol for Renal Transplant Associated Hypertension in Children
Withdrawn before enrolling · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Hypertension, Renal Transplant
In brief
To test the hypothesis that lowering serum uric acid will ameliorate hypertension in children after renal transplantation.
Key facts
- Study ID
- NCT00288171
- Run by
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- People needed
- 0
- Starts
- 2006-02-01
- Expected to finish
- 2008-06-01
- Last updated by the study team
- 2017-09-13
Who can join
Age: 6 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Texas Children's Hospital — Houston, Texas, United States
Full record on ClinicalTrials.gov
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