CKD Stage 3b, CKD Stage 4
Conditions
Brief summary
The aim of this study is to investigate effects of sevelamer carbonate on reducing TMAO in stage 3b-4 CKD (pre-dialysis) patients. The study will also investigate the safety and tolerability of sevelamer carbonate in study population and the effects of sevelamer carbonate on serum p-cresyl sulfate, indoxyl sulfate, LDL-C and uric acid.
Interventions
DRUGSevelamer Carbonate
Sevelamer carbonate 1600mg (p.o. b.i.d) with meals
Sponsors
Fan Fan Hou
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 1\. Men or women, aged from 18 to 75 years old; * 2\. Provide informed consent prior to enrolling in the study; * 3\. Estimated glomerular filtration rate (eGFR) between 15-45 ml/min/1.73 m2 (calculated by CKD-EPI equation)
Exclusion criteria
* 1\. Documented poorly controlled diabetes mellitus, poorly controlled hypertension, malignant tumour, or any clinically significant unstable medical condition; * 2\. Active dysphagia or swallowing disorder; or a predisposition to or current bowel obstruction, ileus, or severe gastrointestinal motility disorders including severe constipation; * 3\. Known hypersensitivity to sevelamer or any constituents of the study drug; * 4\. Unable to comply with the requirements of the study; * 5\. Hypophosphatemia (serum phosphorus level \<0.87mmol/L); * 6\. Women who have a positive pregnancy test at enrollment or women who are breast-feeding; * 7\. Have been enrolled in other interventional study; * 8\. Received sevelamer or other intestinal adsorbents, or broad-spectrum antibiotic within one month prior to the screening period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in the serum concentration of TMAO between treatment group and control group | 22 weeks | The serum concentration of TMAO will be evaluated by high performance liquid chromatography (HPLC) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in the serum concentration of p-cresyl sulfate between treatment group and control group | 22 weeks | The serum concentration of p-cresyl sulfate will be evaluated by high performance liquid chromatography (HPLC) |
| Difference in the serum concentration of indoxyl sulfate between treatment group and control group | 22 weeks | The serum concentration of indoxyl sulfate will be evaluated by high performance liquid chromatography (HPLC) |
| Difference in the serum concentration of LDL-C between treatment group and control group | 22 weeks | Chemistry evaluations |
| Difference in the serum concentration of uric acid between treatment group and control group | 22 weeks | Chemistry evaluations |
Countries
China
Contacts
Primary ContactFan Fan Hou, M.D.,PhD
Outcome results
None listed