Uric Acid Reduction as a Novel Treatment for Pediatric Chronic Kidney Disease

NCT03865407 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: HM20014698
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

Aim 1. To determine the effect of Allopurinol treatment on renal function (glomerular filtration rate, GFR) in pediatric chronic kidney disease (CKD) patients with high uric acid levels (hyperuricemia). Aim 2. Establish whether Allopurinol treatment reduces Nlrp3 inflammasome and renal injury biomarkers.

Conditions

Hyperuricemia; Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (2)

• eGFR Change

  Change in Cys-C eGFR over time

  The difference in Cystatin C eGFR between baseline and 6 months will be measured

• eGFR Change

  Change in Creatinine eGFR over time

  The difference in Creatinine eGFR between baseline and 6 months will be measured

Secondary Outcomes (3)

• Serum Uric Acid Change

  The difference in Serum Uric Acid between baseline and 6 months will be measured

• Systolic Blood Pressure

  The difference in clinic systolic blood pressure between baseline and 6 months will be measured

• Diastolic Blood Pressure

  The difference in clinic diastolic blood pressure between baseline and 6 months will be measured

Other Outcomes (7)

• Serum High Sensitivity C-reactive Protein (Hs-CRP)

  Serum hs-CRP will be measured at baseline and 6 months

• Interleukin 18

  Serum interleukin 18 will be measured at baseline, 3 months, and 6 months

• Serum Nlrp3

  Serum Nlrp3 will be measured at baseline, 3 months, and 6 months

Study Arms (2)

Allopurinol

ACTIVE COMPARATOR

Allopurinol will be administered to this treatment arm group for 6 months. Participants will receive the lowest FDA recommended dose for weight, and will be titrated upwards to achieve the goal uric acid level of 3-5 mg/dL throughout the trial.

Drug: Allopurinol

Standard of Care Control

NO INTERVENTION

The treatment arm will be compared to a standard of care arm.

Interventions

Allopurinol DRUG

Allopurinol dosed to target uric acid levels of 3-5 mg/dL.

Allopurinol

Eligibility Criteria

• Age: 2 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Chronic Kidney Disease stage 1-5
• Hyperuricemic (UA \>= 5.5 mg/dL)

You may not qualify if:

• Contraindication to Allopurinol
• Elevated baseline liver function tests
• Receiving acute or chronic dialysis
• Primary metabolic disorder
• Sickle cell disease
• Autosomal Dominant Polycystic Kidney Disease
• Cystinosis
• Bartter or Gitelman Disease
• Pregnant or nursing

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Hyperuricemia; Renal Insufficiency, Chronic

Interventions

Allopurinol

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Cristin Kaspar, MD
• Organization: Virginia Commonwealth University

cristin.kaspar@vcuhealth.org

804-628-3866

Study Officials

• Cristin Kaspar, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2019
• First Posted: March 6, 2019
• Study Start: March 10, 2019
• Primary Completion: October 7, 2020
• Study Completion: October 7, 2020
• Last Updated: May 27, 2021
• Results First Posted: May 27, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)