Effect of Allopurinol on Markers of Mineral & Bone Metabolism

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

In this randomized double-blind study, patients receive allopurinol or a placebo for 3 months. Dependent variables: 25(OH)-vitamin D, 1,25(OH)2D, FGF-23, PTH, calcium and phosphorus Population: stage 3, 4 or 5 CKD on conservative management at the Nephrology Service of Hospital das Clinicas HCFMUSP, Sao Paulo, Brazil. The same physician will follow patients. Adverse effects will be recorded. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05601271
Study type	Interventional
Source	University of Sao Paulo General Hospital
Contact
Status	Active, not recruiting
Phase	N/A
Start date	March 1, 2021
Completion date	April 30, 2024

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06386172` - Electronic Decision-support System to Improve Detection and Care of Patients With Chronic Kidney Disease in Stockholm	N/A
Recruiting	`NCT04910867` - APOL1 Genetic Testing Program for Living Donors	N/A
Completed	`NCT03434145` - Changes of Ocular Structures After Hemodialysis in Patients With Chronic Kidney Diseases	N/A
Recruiting	`NCT04984226` - Sodium Bicarbonate and Mitochondrial Energetics in Persons With CKD	Phase 2
Active, not recruiting	`NCT05887817` - Effects of Finerenone on Vascular Stiffness and Cardiorenal Biomarkers in T2D and CKD (FIVE-STAR)	Phase 4
Recruiting	`NCT05318196` - Molecular Prediction of Development, Progression or Complications of Kidney, Immune or Transplantation-related Diseases
Terminated	`NCT05022329` - COVID-19 Vaccine Boosters in Patients With CKD	Phase 2/Phase 3
Not yet recruiting	`NCT04925661` - HEC53856 Phase Ib Study in Patients With Non-dialysis Renal Anemia	Phase 1
Recruiting	`NCT04961164` - Resistant Starch Prebiotic Effects in Chronic Kidney Disease	N/A
Completed	`NCT05015647` - Low Protein Diet in CKD Patients at Risk of Malnutrition	N/A
Completed	`NCT03426787` - Helping Empower Liver and Kidney Patients	N/A
Recruiting	`NCT06094231` - Treating Patients With Renal Impairment and Altered Glucose MetAbolism With TherapeutIc Carbohydrate Restriction and Sglt2-Inhibiton - a Pilot Study	N/A
Completed	`NCT04363554` - The Kidneys Ability to Concentrate and Dilute Urine in Patients With Autosomal Dominant Polycystic Kidney Disease	N/A
Recruiting	`NCT04831021` - Pre- or Per-dialytic Physical Exercise : a Cardioprotective Role?	N/A
Terminated	`NCT04877847` - Multi-Center Trial Utilizing Low Frequency Ultrasound in the Prevention of Post-Contrast Acute Kidney Injury	N/A
Recruiting	`NCT04422652` - Combination of Novel Therapies for CKD Comorbid Depression	Phase 2
Completed	`NCT05055362` - Effect a Honey, Spice-blended Baked Good Has on Salivary Inflammation Markers in Adults: a Pilot Study	N/A
Not yet recruiting	`NCT06330480` - Check@Home: General Population Screening for Early Detection of Atrial Fibrillation and Chronic Kidney Disease	N/A
Recruiting	`NCT03176862` - Left Ventricular Fibrosis in Chronic Kidney Disease	N/A
Terminated	`NCT02539680` - Intestinal Phosphate Transporter Expression in CKD Patients	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Effect of Allopurinol on Markers of Mineral and Bone Metabolism

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms