Overview

Allopurinol for Renal Transplant Associated Hypertension in Children

Status:
Withdrawn

Trial end date:
2008-06-01

Target enrollment:
0

Participant gender:
All

Summary

To test the hypothesis that lowering serum uric acid will ameliorate hypertension in children after renal transplantation.

Phase:

Phase 1/Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator:

Baylor University

Treatments:

Allopurinol

Criteria

Inclusion Criteria:

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 Criteria:

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.