Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00288171
Status:
WITHDRAWN
Last Update Posted:
2017-09-13
First Post:
2006-02-06
Brief Title:
Allopurinol for Renal Transplant Associated Hypertension in Children
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Study Overview
Official Title:
Randomized Double-blinded Placebo-controlled Cross-over Trial of Allopurinol for the Treatment of Post-renal-transplant Hypertension in Children
Status:
WITHDRAWN
Status Verified Date:
2017-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
insufficient number of eligible subjects
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Childrens 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 Childrens 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 Childrens 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
Phase 1 The active phase will last six weeks and include a clinic visit on the first day of the phase laboratory testing between day 4 and 7 and weekly telephone contact throughout the phase Subjects will receive allopurinol or placebo Laboratory tests will be performed 4 to 7 days after starting the medication to screen for hepatic or bone marrow toxicity AST ALT CBC renal function Cr cyclosporin or tacrolimus level and serum uric acid Evidence for toxicity increased creatinine or unstable cyclosporin levels will lead to immediate discontinuation of allopurinol withdrawal from the study The families will also be instructed to continue the daily blood pressure log started in the screening phase At the end of the phase prior to discontinuation of the allopurinol children will again undergo 24hr ambulatory blood pressure monitoring Children will repeat the 24-hour urine collection for the purpose of screening urinary nitrates and bradykinin
Washout Phase There will be a two-week washout interval between the allopurinol and placebo phases
Crossover Phase The crossover phase will identical in procedures to the active phase except that the children will be receiving allopurinol or placebo whichever was not received in Phase 1
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 Childrens 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 Childrens 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
Phase 1 The active phase will last six weeks and include a clinic visit on the first day of the phase laboratory testing between day 4 and 7 and weekly telephone contact throughout the phase Subjects will receive allopurinol or placebo Laboratory tests will be performed 4 to 7 days after starting the medication to screen for hepatic or bone marrow toxicity AST ALT CBC renal function Cr cyclosporin or tacrolimus level and serum uric acid Evidence for toxicity increased creatinine or unstable cyclosporin levels will lead to immediate discontinuation of allopurinol withdrawal from the study The families will also be instructed to continue the daily blood pressure log started in the screening phase At the end of the phase prior to discontinuation of the allopurinol children will again undergo 24hr ambulatory blood pressure monitoring Children will repeat the 24-hour urine collection for the purpose of screening urinary nitrates and bradykinin
Washout Phase There will be a two-week washout interval between the allopurinol and placebo phases
Crossover Phase The crossover phase will identical in procedures to the active phase except that the children will be receiving allopurinol or placebo whichever was not received in Phase 1
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| K23DK064587 | NIH | None | httpsreporternihgovquickSearchK23DK064587 |