Calcium Oxalate Stone
Conditions
Interventions
Intervention group:Oxalate Decarboxylase
Sponsors
The First Affiliated Hospital of Xiamen University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Age of 18-65 years old; (2) Patients diagnosed with kidney stones; (3) The longest diameter of urinary calculi was 6-15mm, and there was no obstruction of the urethra or hydronephrosis. (4) The number of single kidney stones was less than or equal to 3. (5) Able to complete the study according to the requirements of the trial protocol. (6) The subjects had no plans to get pregnant (including their spouses) within 3 months after the last dose, and they voluntarily took effective non-drug contraceptive measures, and the males did not donate sperm or the females did not donate eggs. (7) Informed consent for this study.
Exclusion criteria
Exclusion criteria: (1) Previous analysis of stone composition showed no calcium oxalate. (2) In the acute attack stage of calculi, including urethral obstruction, hydronephrosis, renal colic and other symptoms. (3) Persistent urinary tract infection. (4) Those who could not stop vitamin C supplementation during screening and testing. (5) Those who could not stop calcium supplementation during the trial. (6) Patients taking ureteral dilators during the study period. (7) Patients who plan to undergo surgical/invasive procedures during the trial; (8) Patients with severe digestive diseases (e.g., acute peptic ulcer, chronic ulcerative colitis, localized enteritis, intestinal obstruction); (9) Malignancy or treatment for malignancy within 12 months before screening (other than local basal or squamous cell carcinoma or any carcinoma in situ); (10) Patients with cerebrovascular diseases (cerebral infarction, cerebral hemorrhage, etc.) or cardiovascular diseases (congestive heart failure of NYHA class ? or above, acute myocardial infarction, unstable angina, etc.) within 6 months before admission were screened; (11) Patients with active autoimmune diseases or diseases requiring systemic steroid therapy; (12) Uncontrolled hypertension and diabetes; (13) Have participated in any drug or device clinical trial within 90 days before screening, and if there is a history of participating in a clinical trial, it is necessary to record the history of participating in a clinical trial; (14) Previous diagnosis of hypercalcemia or hypothyroidism; (15) Other reasons for not participating in the trial considered by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stone resolution (including spontaneous passage);Significant reduction in stone size (=20% decrease); | — |
Secondary
| Measure | Time frame |
|---|---|
| Urinary oxalate;Urinary calcium;Urinary magnesium;Urinary citric acid;Urinary uric acid; | — |
Countries
China
Contacts
Public ContactChen Bin
The First Affiliated Hospital of Xiamen University
Outcome results
None listed