Patients with chronic renal failure undergoing hemodialysis
Conditions
Sponsors
FUSO Pharmaceutical Industries, Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients with chronic renal failure undergoing hemodialysis for 3 to less than 6 hours per session, 3 times a week, in the last week before the period of pre-observation (2) Patients aged 20 to 80 years old at the time of informed consent (3) Patients providing written informed consent about participation in this clinical study
Exclusion criteria
Exclusion criteria: (1) Patients within 12 weeks of initiating hemodialysis at the time of informed consent (2) Patients with severe hepatic function impairment (3) Patients with severe heart disease (4) Patients with severe respiratory disorder (5) Female patients who are pregnant, lactating, or who have the possibility of pregnancy which cannot be denied by quantitative hCG blood test at the time of enrollment and allocation, or female patients who cannot prevent conception from the time of informed consent through the period of post-observation (6) Patients participated in another clinical study within 12 weeks before the time of informed consent (7) Patients judged by the investigator or sub-investigator to be inadequate for this study due to any other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| confirmatory efficacy Correction of azotemia (BUN, Cre, and UA) | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy (1) Correction of serum electrolytes (Na, K, adjusted Ca, and Mg) (2) Correction of blood acid-base balance (HCO3-) (3) Temporal change in azotemia (BUN, Cre, and UA) (4) Temporal change in serum electrolytes (Na, K, Cl, total Ca, adjusted Ca, iCa, Mg, and Pi) (5) Temporal change in blood acid-base balance (HCO3-, pH) (6) Evaluation of removal status (Kt/V, n-PCR) of hemodialysis volume (small molecular substances) (7) Temporal change in blood pressure (SBP, DBP, and MBP) and pulse (8) Maintenance of blood glucose (9) Temporal change in iPTH safety (1) Adverse events (2) Abnormal change in laboratory values (3) Temporal change in laboratory values (4) Temporal change in vital signs | — |
Countries
Japan
Outcome results
None listed