Hyperuricemia Clinical Trial
Official title:
Effect of Oxalate and Urate Metabolism on the Evolution of Kidney Disease
The current study primarily aimed to characterize the oxalate and uric acid metabolism in CKD patients and to analyze its association with renal survival prognosis. Secondarily, the study is planned to determine whether hyperoxalemia and hyperuricemia are independent risk factors for cardiovascular events and mortality.
The study protocol is approved by a local Ethics Committee and registered in Domestic
Clinical Trial Registry (Identifier 0119U000002). Writing informed consent is obtained from
all subjects participating in the study.
The study will enroll 300 participants (250 CKD patients at stage 1-5 and 50 healthy
subjects). Routine biochemical parameters including blood and daily dialysate concentration
of urea and creatinine, serum albumin, C-reactive protein (CRP), glucose, electrolytes, and
lipid profile parameters will carry out. Total oxalate-degrading activity in fecal samples,
as well as plasma oxalic acid concentration, daily urinary oxalate excretion and peritoneal
dialysis effluent oxalate concentration (if any) will determine. Uric acid will also measure
in serum, urine and dialysate of peritoneal dialysis patients.
The study will be followed up for 3 years. The primary endpoint is cardiovascular events,
secondary endpoints are dialysis adequacy and all-cause mortality. All the endpoints will be
collected, as well as other outcomes, such as chronic inflammation, dyslipidemia and dialysis
dose, and so on. The outcomes will be analyzed using statistical software.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05434858 -
Imagery as Biomarker of Gout
|
N/A | |
| Completed |
NCT04060173 -
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ABP-671
|
Phase 1 | |
| Recruiting |
NCT05504083 -
Evaluate the Efficacy and Safety of D-0120 in Primary Hyperuricemia Patients
|
Phase 2 | |
| Completed |
NCT04966325 -
Thorough QT (TQT) Study to Evaluate the Effect of LC350189 on Cardiac Repolarization in Healthy Male and Female Subjects
|
Early Phase 1 | |
| Completed |
NCT01407874 -
A Randomized, Double-Blind, Dose-Response Study of the Safety and Uric Acid Effects of Oral Ulodesine Added to Allopurinol in Subjects With Gout and Concomitant Moderate Renal Insufficiency
|
Phase 2 | |
| Completed |
NCT00995618 -
Study of Tranilast Alone or in Combination With Febuxostat in Patients With Hyperuricemia
|
Phase 2 | |
| Completed |
NCT00288158 -
Primary Prevention of Hypertension in Obese Adolescents
|
Phase 2 | |
| Terminated |
NCT04987294 -
Phase IIa Study of ALLN-346 (Engineered Urate Oxidase) in Subjects With Hyperuricemia, Gout and Chronic Kidney Disease
|
Phase 2 | |
| Completed |
NCT04236219 -
ALLN-346 Single Ascending Dose (SAD) Study in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT06189404 -
Effect of Tigulixostat on the Pharmacokinetics of Theophylline
|
Phase 1 | |
| Recruiting |
NCT05586958 -
Tigulixostat, Phase 3 Study, Placebo Controlled in Gout Patients
|
Phase 3 | |
| Recruiting |
NCT06084585 -
The Efficacy of Amway Uric Acid Lowering Product on Hyperuricemia
|
N/A | |
| Recruiting |
NCT06056570 -
Open Label PK, PD and DDI of Dotinurad and Allopurinol in Gout Patients With Hyperuricemia
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT04586803 -
Study on the Bioavailability of Three Different Prescription Processes of SHR4640 Tablets in Healthy Volunteers
|
Phase 1 | |
| Not yet recruiting |
NCT02944214 -
Compare the Renal Protective Effects of Febuxostat and Benzbromarone in CKD Chinese Patients
|
N/A | |
| Completed |
NCT02959918 -
Multi-Dose Safety/Pharmacodynamic Study of SEL-212/SEL-037 in Subjects With Symptomatic Gout & Elevated Blood Uric Acid
|
Phase 2 | |
| Completed |
NCT02557126 -
Study of URC102 to Assess the Safety and Efficacy in Gout Patients
|
Phase 2 | |
| Active, not recruiting |
NCT01021241 -
Safety and Efficacy Study of Intravenous Uricase-PEG 20
|
Phase 1 | |
| Completed |
NCT00756964 -
Lowering Serum Uric Acid to Prevent Acute Kidney Injury
|
Phase 2 | |
| Terminated |
NCT00607152 -
Rasburicase (Fasturtec) Registration Trial
|
Phase 3 |