NCT05601271

Brief Summary

Hyperuricemia is a common condition in patients with chronic kidney disease (CKD) in the glomerular filtration rate. Recently, it has been suggested that uric acid is related to a mineral and bone disease of CKD (CKD-MBD) since the high concentration of uric acid is associated with the harmful effect of vitamin D. The proof of concept of the association between acid uric acid and CKD-MBD is based on a prospective study (sample size 6) that observed, after 1 week of use of allopurinol, an increase in the concentration of 1,25(2D, a result independent of the concentration of calcium, phosphorus, 25(OH)D and PTH. An experimental study found that hyperuricemia could modify the expression of the 1α-hydroxylase enzyme, consequently reducing 1,25(OH). The current study aims to evaluate the action of allopurinol on CKD-MBD biomarkers (25(OH)-vitamin D, 1,25(OH)2D, FGF-23, PTH, calcium and phosphorus). We hypothesize that allopurinol can improve serum levels of 1,25(OH) 2D and PTH. This is a controlled, randomized, double-blind study, defined as a filtration rate \< 60ml/1.73 m², according to the CKD-EPI equation. Inclusion criteria: patients with stages III, IV and V CKD who are not on dialysis with a serum level of 25(OH)-vitamin D \>20 ng/ml. Exclusion criteria: Patients diagnosed with gout, undergoing treatment with allopurinol, patients already in use and drugs with sensitivity to the drug. Based on a previous study, we calculated a sample for 2 groups (placebo and drug) with pre and post-measurements (a total of 4). Considering a standard deviation of 4 and a difference of 7 in the treated group, 3 in the placebo group, and an alpha error of 5%, we calculated a sample of 25 patients in each arm.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 26, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 1, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

April 2, 2025

Status Verified

December 1, 2024

Enrollment Period

4 years

First QC Date

October 26, 2022

Last Update Submit

March 27, 2025

Conditions

Chronic Kidney DiseasesOsteodystrophyUric Acid Concentration, Serum, Quantitative Trait Locus 7

Keywords

chronic kidney diseaseallopurinolmineral and bone metabolismuric acidvitamin D

Outcome Measures

Primary Outcomes (3)

  • 1,25 dihydroxivitamin D

    Increase in 1,25 dihydroxivitamin D

    3 months

  • FGF-23

    Reduction of FGF-23

    3 months

  • Klotho

    Increase in alpha Klotho

    3 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

pills exactly as the drug will be delivered to participants. Instructions will be made to take the pill once a day.

Drug: Allopurinol

Allopurinol

ACTIVE COMPARATOR

pills exactly as the placebo will be delivered to participants. Instructions will be made to take the pill once a day.

Drug: Allopurinol

Interventions

AllopurinolDRUG

Allopurinol 100 to 300 mg a day for 3 months

AllopurinolPlacebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • allergy to allopurinol
  • current treatment with allopurinol
  • Gout

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital das Clinicas HCFMUSP

São Paulo, São Paulo, 05403000, Brazil

Location

MeSH Terms

Conditions

Renal Insufficiency, ChronicCalcinosis

Interventions

Allopurinol

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCalcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

PurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Ph.D, assistent nephrologist

Study Record Dates

First Submitted

October 26, 2022

First Posted

November 1, 2022

Study Start

March 1, 2021

Primary Completion

March 1, 2025

Study Completion

March 1, 2025

Last Updated

April 2, 2025

Record last verified: 2024-12

Locations

BR(1)