Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 12:14 PM
Ignite Modification Date:
2025-12-26 @ 12:14 PM
NCT ID:
NCT04551300
Eligibility Criteria:
Inclusion Criteria:
* Adults with end stage renal disease who are receiving a stable hemodialysis regimen (3 times per week) with sufficient dialysis adequacy;
* Serum phosphorus level range from \>1.94 mmol/L (6.0 mg/dL) to ≤3.23 mmol/L (10.0 mg/dL) at the end of washout phase.
Exclusion Criteria:
* Kidney transplant patient or scheduled kidney transplant, or change to peritoneal dialysis, home hemodialysis or plan to relocate to another dialysis center during the study period；
* Serum phosphorus level is \<1.29 mmol/L（4.0 mg/dL) or \>2.42 mmol/L（7.5 mg/dL) at screening, or documented to be \>3.23 mmol/L（10 mg/dL) within the latest three month prior to screening (screening included);
* Serum calcium level is \<8 mg/dL or \>11 mg/dL at the screening;
* Serum immunoreactive parathyroid hormone (iPTH)\>1000 pg/mL at the screening;
* History of hemochromatosis or serum ferritin value ≥1000 μg/L at screening；
* Current clinically significant gastrointestinal (GI) disorder, or history of intestine obstruction, gastrectomy or duodenectomy, or GI tract surgery within 12 weeks prior to screening;
* Poorly controlled hypertension, cardiovascular disorders, and history of cerebrovascular disease or cardiovascular disease event within 24 weeks (6 months) prior to screening.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04551300
Study Brief:
Protocol Section:
NCT04551300