A Randomized Clinical Trail of The Effect of Postoperative Uric Acid Control on Stone Recurrence and Renal Function in Patients With Hyperuricemia of Urolithiasis.

NCT04398251 | Unknown Phase 4 DMC

• 1 other identifier: 2020-043
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to explore the effects of uric acid control on stone recurrence and renal function in patients with calculi of hyperuricemia through a prospective controlled study.

Conditions

Hypouricemia, Renal; Urolithiasis

Keywords

Stone prevention; Renal function; Febuxostat

Outcome Measures

Primary Outcomes (4)

• Stone burdern stone burdern

  Use ultrasound or kub or CT plain scan to follow up the patients.

  Change from the base line of the stone's volume and quantity at 3 months.

• Stone burdern stone burdern

  Use ultrasound or kub or CT plain scan to follow up the patients.

  Change from the base line of the stone's volume and quantity at 6 months.

• Stone burdern stone burdern

  Use ultrasound or kub or CT plain scan to follow up the patients.

  Change from the base line of the stone's volume and quantity at 12 months.

• Stone burdern stone burdern

  Use ultrasound or kub or CT plain scan to follow up the patients.

  Change from the base line of the stone's volume and quantity at 18 months.

Secondary Outcomes (3)

• Renal function

  Change from the base line of GFR at 6 months after the operation.

• Renal function

  Change from the base line of GFR at 12 months after the operation.

• Renal function

  Change from the base line of GFR at 18 months after the operation.

Other Outcomes (4)

• Serum uric acid level

  Chage from the base line at 3 months after the operation

• Serum uric acid level

  Chage from the base line at 6 months after the operation

• Serum uric acid level

  Chage from the base line at 12 months after the operation

Study Arms (2)

Uric acid drug control group

EXPERIMENTAL

For the uric acid control group, except that lifestyle changes were the same as those in the uric acid non-drug control group, non-drug uric acid control group was given febuxostat to reduce uric acid synthesis. Febuxostat is taken at a dose of 40 mg three times a week

Drug: Febuxostat 40mg Tab

Non-drug control group

ACTIVE COMPARATOR

They are advised to live regularly after operation, drink plenty of water, drink more than 2000ml every day, reduce the intake of high purine food and fructose-rich beverages, increase the intake of fresh vegetables, control weight and exercise regularly.

Behavioral: Non-drug control group

Interventions

Febuxostat 40mg Tab DRUG

For the uric acid control group, except that lifestyle changes were the same as those in the uric acid non-drug control group, non-drug uric acid control group was given febuxostat to reduce uric acid synthesis. Febuxostat is taken at a dose of 40 mg three times a week.

Uric acid drug control group

Non-drug control group BEHAVIORAL

All patients in the group are advised to live regularly after operation, drink plenty of water, drink more than 2000ml every day, reduce the intake of high purine food and fructose-rich beverages, increase the intake of fresh vegetables, control weight and exercise regularly

Non-drug control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 18 years old, under 70 years old, regardless of sex .The subjects had no mental illness or language dysfunction, could understand the situation of this study and had signed an informed consent form.
• No clinical manifestations of urinary tract infection, urinary routine examination showed urinary tract infection, but urinary etiology test was negative (urinary routine leukocytosis), treated with broad-spectrum antibiotics for more than 3 days.
• Clinical manifestations of urinary tract infection, urine routine examination showed urinary tract infection, and patients with positive urinary etiology were treated with sensitive antibiotics for more than 7 days.
• Serum uric acid value ≥480 µmol / L
• urinary stones

You may not qualify if:

• Transplanted kidney
• Pregnant women and female menstruation
• Unable to tolerate anesthesia or surgery due to severe systemic disease, heart disease, pulmonary insufficiency and important organ failure
• Patients with renal insufficiency Clcr \<30 mL/min
• Those who take side effects of febuxostat，Patients with side effects of febuxostat, patients with a previous history of coronary heart disease

Sponsors & Collaborators

• Xuhui Central Hospital, Shanghai: lead

Study Sites (1)

Shanghai Xuhui Central Hospital

Shanghai, Shanghai Municipality, 200031, China

Location

MeSH Terms

Conditions

Renal hypouricemia; Urolithiasis

Interventions

Febuxostat

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• JianMing Guo, PHD,M.D

  Department of Urology, Zhongshan Hospital, Shanghai

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Make a random table, and the patients are divided into the group according to the random table according to the order of enrollment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Urology

Model Details: 2020.1 -2020.12 patients with urolithiasis and hyperuricemia were enrolled in the urology department of our hospital (100 cases). The patients were informed of this study before operation and randomly divided into uric acid drug control group (n = 50) and non-drug control group (n = 50). For non-drug control group: Patients are advised to live regularly after operation, drink plenty of water, drink more than 2000ml every day, reduce the intake of high purine food and fructose-rich beverages, increase the intake of fresh vegetables, control weight and exercise regularly. Uric acid drug control group:or the uric acid control group, except that lifestyle changes were the same as those in the uric acid non-drug control group, non-drug uric acid control group was given febuxostat to reduce uric acid synthesis. Febuxostat is taken at a dose of 20 mg three times a week

Study Record Dates

• First Submitted: May 7, 2020
• First Posted: May 21, 2020
• Study Start: April 10, 2020
• Primary Completion: March 31, 2022
• Study Completion: May 31, 2022
• Last Updated: May 21, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)