Randomized Double-blinded, Placebo-controlled, Cross-over Trial of Allopurinol for the Treatment of Post-renal-transplant Hypertension in Children
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Systolic Blood Pressure
研究概览
简要总结
To test the hypothesis that lowering serum uric acid will ameliorate hypertension in children after renal transplantation.
详细描述
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 Hospital. The study consists of three phases, a screening phase, and a treatment phase, and a crossover phase.
Clinical study design: 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 Hospital. The study consists of three phases, a screening phase, and a treatment phase, and a crossover phase.
Laboratory Measurements: The laboratory measurements will be performed in the CLIA approved, clinical laboratory at Texas Children's Hospital.
Definition of high blood pressure: We will use the guidelines for blood pressure measurement that have been adapted from the Update on the Task Force Report (1987) on High Blood Pressure in Children and Adolescents [22]. Hypertension will be defined as >95th percentile blood pressure for age, height percentile (rounded to the nearest of 5th, 10th, 25th, 50th, 75th, 90th, or 95th percentile of height above the patients actual height) and gender. Each blood pressure measurement will be the mean of 3 right arm readings, taken with an mercury sphygmomanometer at least three minutes apart with the patient sitting upright and relaxed. For the purposes of the study, to be defined as hypertensive, a patient will need to have mean systolic or diastolic blood pressure >95th percentile on three consecutive occasions, on separate days over at least a 1 week period. Patients with previously confirmed hypertension will be reconfirmed during the screening period.
Screening phase: The screening phase will last between 1 and 2 weeks. Patients will be taught to use a digital blood pressure monitor with an appropriately sized cuff and be instructed to perform daily blood pressure measurements and keep a blood pressure log. Blood tests will be done to determine eligibility based on clinical laboratory parameters. Girls who are post-menarche will have a urine pregnancy test. Each child will undergo 24hr ambulatory blood pressure monitoring during the screening phase. Children will collect urine for 24-hours for the purpose of screening urinary nitrates and bradykinin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Allopurinal
Hypertensive renal transplant recipients with elevated uric acid will the treated with allopurinol and placebo in an randomized cross over fashion. Subjects will serve as their own controls.
干预措施: Allopurinol (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Systolic Blood Pressure
时间窗: 2 months
次要结局
- Serum Creatinine(2 months)
- urinary bradykinin(2 months)
- urinary nitrates(2 months)