Allopurinol for Renal Transplant Associated Hypertension in Children

NCT00288171 | Withdrawn Phase 1 FDA Drug

• 2 other identifiers: DK64587-POST (terminated)K23DK064587
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypertension; Renal Transplant

Outcome Measures

Primary Outcomes (1)

• Systolic Blood Pressure

  2 months

Secondary Outcomes (3)

• Serum Creatinine

  2 months

• urinary bradykinin

  2 months

• urinary nitrates

  2 months

Study Arms (2)

Allopurinal

EXPERIMENTAL

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.

Drug: Allopurinol

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Placebo DRUG

placebo capsule twice daily for one month

Placebo

Allopurinol DRUG

Allopurinol 200mg twice daily for one month

Allopurinal

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead
• Baylor University: collaborator

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

Allopurinol

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Daniel I Feig, MD, PhD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2006
• First Posted: February 7, 2006
• Study Start: February 1, 2006
• Primary Completion: January 1, 2008
• Study Completion: June 1, 2008
• Last Updated: September 13, 2017

Record last verified: 2017-09

Locations

US (1)