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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04398251
Other study ID # 2020-043
Secondary ID
Status Enrolling by invitation
Phase Phase 4
First received
Last updated
Start date April 10, 2020
Est. completion date May 31, 2022

Study information

Verified date May 2020
Source Xuhui Central Hospital, Shanghai
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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). The patients were followed up for 3 months, 6 months, 12 months and 18 months after operation.

Informations as age, sex, height, weight, calculation BMI, past medical history, history of gout, diabetes, hyperthyroidism, calcium supplements will be recorded.

Rapid blood glucose, serum total cholesterol, high density cholesterol, thyroid hormone detection, androgen, estrogen detection, serum sodium, potassium, chlorine, calcium, magnesium, phosphorus, serum uric acid will be tested.

Renogram test to evaluate the change of single renal function. The stones burden will be followed-up with ultrasound or kub or CT plain scan.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 100
Est. completion date May 31, 2022
Est. primary completion date March 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- .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

Exclusion Criteria:

- Transplanted kidney

- Fever or urinary tract infection is not treated according to the inclusion criteria

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Febuxostat 40mg Tab
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.
Behavioral:
Non-drug control group
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

Locations

Country Name City State
China Shanghai Xuhui Central Hospital Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Xuhui Central Hospital, Shanghai

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Serum uric acid level Serum uric acid level Chage from the base line at 3 months after the operation
Other Serum uric acid level Serum uric acid level Chage from the base line at 6 months after the operation
Other Serum uric acid level Serum uric acid level Chage from the base line at 12 months after the operation
Other Serum uric acid level Serum uric acid level Chage from the base line at 18 months after the operation
Primary 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.
Primary 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.
Primary 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.
Primary 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 Renal function Total and partial renal function Change from the base line of GFR at 6 months after the operation.
Secondary Renal function Total and partial renal function Change from the base line of GFR at 12 months after the operation.
Secondary Renal function Total and partial renal function Change from the base line of GFR at 18 months after the operation.
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