Completed

Allopurinol Impact on Mineral and Bone Metabolism in Chronic Kidney Disease Patients

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Study Aim

This study aims to evaluate the impact of Allopurinol treatment on mineral and bone metabolism in patients with Chronic Kidney Disease, specifically focusing on increasing 1,25 dihydroxivitamin D and alpha Klotho levels, while reducing FGF-23.

What is being tested

Allopurinol

Drug
Who is being recruted

Urogenital Diseases+13

+ Calcinosis

+ Calcium Metabolism Disorders

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: March 2021
See protocol details

Summary

Principal SponsorUniversity of Sao Paulo General Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2021

Actual date on which the first participant was enrolled.

This study focuses on understanding the impact of a medication called Allopurinol on bone and mineral health in patients with Chronic Kidney Disease (CKD). The research takes place in Sao Paulo, Brazil, and involves patients in stages 3, 4, or 5 of CKD who are under conservative management at the Nephrology Service of Hospital das Clinicas HCFMUSP. The study aims to find out if Allopurinol can improve bone health and mineral balance in these patients, which could lead to better care and quality of life for individuals living with CKD. During the study, patients receive either Allopurinol or a placebo (a pill with no active ingredients) for 3 months. The effects of these treatments on bone health and mineral balance are measured through changes in specific substances in the body, such as 1,25 dihydroxivitamin D, FGF-23, and alpha Klotho. Patients are monitored by the same physician throughout the study, and any adverse effects are recorded.

Official TitleEffect of Allopurinol on Markers of Mineral and Bone Metabolism in Patients in With Chronic Kidney Disease: a Randomized Double-blind Study
NCT05601271
Principal SponsorUniversity of Sao Paulo General Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesCalcinosisCalcium Metabolism DisordersChronic DiseaseFemale Urogenital Diseases and Pregnancy ComplicationsKidney DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsUrologic DiseasesDisease AttributesRenal Insufficiency, ChronicRenal InsufficiencyFemale Urogenital DiseasesMale Urogenital Diseases

Criteria

Inclusion Criteria: stage 3, 4 or 5 CKD on conservative management \- Exclusion Criteria: * allergy to allopurinol * current treatment with allopurinol * Gout

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

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

Group II

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

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Hospital das Clinicas HCFMUSP

São Paulo, BrazilOpen Hospital das Clinicas HCFMUSP in Google Maps
CompletedOne Study Center