HyperuricemiaPhase 2NCT03865407
Uric Acid Reduction as a Novel Treatment for Pediatric Chronic Kidney Disease
A Phase 2 study testing Allopurinol in people with Hyperuricemia and Chronic Kidney Diseases, run by Virginia Commonwealth University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 20 years
- Conditions the study is for
- Hyperuricemia, Chronic Kidney Diseases
- What is being tested?
- Allopurinol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2019to 7 Oct 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Chronic Kidney Disease stage 1-5
- Hyperuricemic (UA >= 5.5 mg/dL)
Who cannot join
- Contraindication to Allopurinol
- Elevated baseline liver function tests
- Receiving acute or chronic dialysis
- Primary metabolic disorder
- Sickle cell disease
- Autosomal Dominant Polycystic Kidney Disease
Show all 9Show fewer
- Cystinosis
- Bartter or Gitelman Disease
- Pregnant or nursing
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
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.
Read the detailed description
Uric acid levels often rise when kidney function declines. Historically, high uric acid has not been treated unless the uric acid crystallizes in the joint space and causes clinical gout disease, more typically seen in adults. However, new research has shown that high uric acid levels are associated with the development of hypertension, inflammation, and both acute and chronic kidney injury. Adult patients on renal dialysis who have hyperuricemia also have higher mortality rates. In several adult and in one pediatric clinical trial of uric acid lowering therapy (with Allopurinol or Febuxostat), treatment has demonstrated a slower rate of renal function decline and improved blood pressure compared to placebo. The pediatric trial was a 4-month placebo controlled trial of Allopurinol, and showed positive improvement in renal function and blood pressure, but did not adequately control for potential confounders in the outcome. Two known confounders that influence renal function (glomerular filitration rate, GFR) in pediatric CKD are race and glomerular or non-glomerular disease etiology. This study is designed to control for these confounders and establish whether Allopurinol for 6 months of treatment to a goal range of 3-5 mg/dL will improve renal function compared to standard of care. The secondary outcome is to determine whether blood pressure is affected by the treatment and the magnitude of change of serum uric acid. This study will also explore whether Allopurinol treatment alters activation of the Nlrp3 inflammasome or renal injury biomarkers.
- Conditions
- Hyperuricemia, Chronic Kidney Diseases
- Being tested
- Allopurinol
- Medical subject headings
- Hyperuricemia, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AllopurinolDrug
Allopurinol dosed to target uric acid levels of 3-5 mg/dL.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Allopurinol |
| Standard of Care Control | No intervention | The treatment arm will be compared to a standard of care arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
eGFR Change
Change in Cys-C eGFR over time
Measured: The difference in Cystatin C eGFR between baseline and 6 months will be measured
eGFR Change
Change in Creatinine eGFR over time
Measured: The difference in Creatinine eGFR between baseline and 6 months will be measured
Secondary outcomes (3)
Serum Uric Acid Change
Change in Serum Uric Acid
Measured: The difference in Serum Uric Acid between baseline and 6 months will be measured
Systolic Blood Pressure
Change in systolic blood pressure
Measured: The difference in clinic systolic blood pressure between baseline and 6 months will be measured
Diastolic Blood Pressure
Change in diastolic blood pressure
Measured: The difference in clinic diastolic blood pressure between baseline and 6 months will be measured
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2019
- Study start10 Mar 2019
- Primary completion7 Oct 2020
- Study completion7 Oct 2020
Why it stopped: inability to achieve recruitment goals at a single center and given the current pandemic conditions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HyperuricemiaStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cristin Kaspar, MD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03865407
- Sponsor's protocol ID
- HM20014698
- Status last verified
- May 2021
- First submitted
- 5 Mar 2019
- Last updated
- 27 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uric Acid Reduction as a Novel Treatment for Pediatric Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT03865407
- Acronym / sponsor ID
- HM20014698
- Conditions
- Hyperuricemia, Chronic Kidney Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: inability to achieve recruitment goals at a single center and given the current pandemic conditions
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 10 Mar 2019 (actual)
- Primary completion
- 7 Oct 2020 (actual)
- Study completion
- 7 Oct 2020 (actual)
- First posted
- 6 Mar 2019 (actual)
- Results
- Posted 27 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Uric acid levels often rise when kidney function declines. Historically, high uric acid has not been treated unless the uric acid crystallizes in the joint space and causes clinical gout disease, more typically seen in adults. However, new research has shown that high uric acid levels are associated with the development of hypertension, inflammation, and both acute and chronic kidney injury. Adult patients on renal dialysis who have hyperuricemia also have higher mortality rates. In several adult and in one pediatric clinical trial of uric acid lowering therapy (with Allopurinol or Febuxostat), treatment has demonstrated a slower rate of renal function decline and improved blood pressure compared to placebo. The pediatric trial was a 4-month placebo controlled trial of Allopurinol, and showed positive improvement in renal function and blood pressure, but did not adequately control for potential confounders in the outcome. Two known confounders that influence renal function (glomerular filitration rate, GFR) in pediatric CKD are race and glomerular or non-glomerular disease etiology. This study is designed to control for these confounders and establish whether Allopurinol for 6 months of treatment to a goal range of 3-5 mg/dL will improve renal function compared to standard of care. The secondary outcome is to determine whether blood pressure is affected by the treatment and the magnitude of change of serum uric acid. This study will also explore whether Allopurinol treatment alters activation of the Nlrp3 inflammasome or renal injury biomarkers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allopurinol | Active comparator | Drug: AllopurinolAllopurinol 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. |
| Standard of Care Control | No intervention | –The treatment arm will be compared to a standard of care arm. |
Who may qualify
- Ages
- 2 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Chronic Kidney Disease stage 1-5
- Hyperuricemic (UA >= 5.5 mg/dL)
Key exclusion criteria (9 listed)
- Contraindication to Allopurinol
- Elevated baseline liver function tests
- Receiving acute or chronic dialysis
- Primary metabolic disorder
- Sickle cell disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AllopurinolAllopurinol dosed to target uric acid levels of 3-5 mg/dL. | Drug | Allopurinol |
Primary outcome
eGFR Change
Time frame: The difference in Cystatin C eGFR between baseline and 6 months will be measured
Change in Cys-C eGFR over time
eGFR Change
Time frame: The difference in Creatinine eGFR between baseline and 6 months will be measured
Change in Creatinine eGFR over time
3 secondary outcomes
Serum Uric Acid Change
Time frame: The difference in Serum Uric Acid between baseline and 6 months will be measured
Systolic Blood Pressure
Time frame: The difference in clinic systolic blood pressure between baseline and 6 months will be measured
Diastolic Blood Pressure
Time frame: The difference in clinic diastolic blood pressure between baseline and 6 months will be measured
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cristin Kaspar, MD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Allopurinol in people with Hyperuricemia and Chronic Kidney Diseases, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
eGFR Change (time frame: The difference in Cystatin C eGFR between baseline and 6 months will be measured). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2021; AzTrials last refreshed its copy on 7 Nov 2026.