Effect of Oxalate and Urate Metabolism on CKD Evolution
Ключови думи
Резюме
Описание
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.
Дати
| Последна проверка: | 04/30/2020 |
| Първо изпратено: | 05/18/2020 |
| Очаквано записване подадено: | 05/18/2020 |
| Първо публикувано: | 05/21/2020 |
| Изпратена последна актуализация: | 05/18/2020 |
| Последна актуализация публикувана: | 05/21/2020 |
| Действителна начална дата на проучването: | 01/09/2019 |
| Приблизителна дата на първично завършване: | 11/30/2021 |
| Очаквана дата на завършване на проучването: | 11/30/2024 |
Състояние или заболяване
Фаза
Групи за ръце
| Arm | Интервенция / лечение |
|---|---|
| Hyperoxalemia/Hyperuricemia Group | |
| Hyperoxalemia/Hyperuricemia-free Group | |
| Healthy Subjects |
Критерии за допустимост
| Възрасти, отговарящи на условията за проучване | 18 Years Да се 18 Years |
| Полове, допустими за проучване | All |
| Метод за вземане на проби | Non-Probability Sample |
| Приема здрави доброволци | Да |
| Критерии | Inclusion Criteria: - age >18 years old, - CKD stage 1-4, - the patients did not take antibiotics and/or probiotics, lipid- and/or urate-lowering therapy for at least past 3 months or: - dialysis treatment for at least 3 months, - a stable clinical condition and adequately functioning arteriovenous fistula or peritoneal access, - a target level of Kt/V (≥ 1.4 for the HD patients and ≥1.7 for the PD patients). Exclusion Criteria: - hospitalization in the preceding 3 months, - previous history or actual diagnosis of peritonitis, anemia, systemic and malignant diseases, acute inflammation processes, immunosuppressive treatment and active hepatitis. |
Резултат
Първични изходни мерки
1. Renal Survival for CKD stages 1-3 [3 years]
Вторични изходни мерки
1. Cardio-vascular Events [3 years]
