Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01850641
Other study ID # PA1304
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date April 29, 2013
Est. completion date December 3, 2013

Study information

Verified date November 2014
Source Kissei Pharmaceutical Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to investigate the safety and efficacy when administering PA21 with calcium carbonate in hemodialysis patients with hyperphosphatemia for 12 weeks.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date December 3, 2013
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria:

- Receiving stable maintenance hemodialysis 3 times a week

- Dialysis patients with hyperphosphatemia

Exclusion Criteria:

- Patients having history of a pronounced brain / cardiovascular disorder

- Patients having severe gastrointestinal disorders

- Patients having severe hepatic disorders

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
PA21


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Kissei Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Adverse Events 12 weeks
Secondary Serum Phosphorus Concentrations at End of Treatment (Actual Measured Value) 12 weeks
Secondary Corrected Serum Calcium Concentrations at End of Treatment (Actual Measured Value) 12 weeks
Secondary Serum Intact-PTH Concentrations at End of Treatment (Actual Measured Value) 12 weeks
Secondary Serum Ferritin Concentrations at End of Treatment (Actual Measured Value) 12 weeks
Secondary TSAT at End of Treatment (Actual Measured Value) 12 weeks
Secondary Hb Concentrations at End of Treatment (Actual Measured Value) 12 weeks
Secondary Constipation Condition 12 weeks
Secondary Satisfaction With Bowel Movement 12 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT04892745 - Impact of Hemodialysis on Cutaneo-muscular Electrical Impedance
Not yet recruiting NCT04925674 - Study of HEC53856 in Patients With Subjects With End-Stage Renal Disease Receiving Dialysis. Phase 1
Active, not recruiting NCT03183245 - Comparison of the Human Acellular Vessel (HAV) With Fistulas as Conduits for Hemodialysis Phase 3
Completed NCT03365635 - Administration of Zepatier (Grazoprevir Plus Elbasvir) in Chronic Hemodialysis (HD) Patients With Hepatitis C Phase 4
Withdrawn NCT02904343 - Evaluation of Domestic Hemodialysis Machine: A Multi-center Clinical Study N/A
Withdrawn NCT01855334 - L-Arginine and Spironolactone Trial in Dialysis-Dependent ESRD Phase 4
Completed NCT01700465 - Estimating and Predicting Hemodynamic Changes During Hemodialysis N/A
Recruiting NCT01195519 - The Assessment of Quality of Life in Patients With Peritoneal Dialysis and Hemodialysis N/A
Completed NCT00737672 - GORE VIABAHN Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise AV Grafts in Hemodialysis Phase 3
Completed NCT00527774 - Effect of HCV Infection on Insulin Resistance and Malnutrition-inflammation Complex Syndrome in Regular Hemodialysis Patients N/A
Completed NCT00942253 - Exercise Training in Dialysis Patients With Restless Legs Syndrome (RLS) Phase 2
Completed NCT00850252 - Use of a Lifeline Graft in the A-V Shunt Model Phase 1/Phase 2
Completed NCT00224081 - DRIVE Trial (Dialysis Patients' Response to Intravenous [IV] Iron With Elevated Ferritin) Phase 4
Completed NCT00776750 - Influenza Vaccination in Hemodialysis Patients and Renal Transplant Recipients Phase 4
Recruiting NCT06351007 - Educational Program on Dietary Adherence and Nutritional Knowledge in Chronic Kidney Disease Patients (EPAK) N/A
Withdrawn NCT03664141 - Impact of Cannabis Oil on Nutrition in Hemodialysis Patients Study (ICON-HP Study) Phase 3
Completed NCT03909698 - Antibiotic Dosing in Patients on Intermittent Hemodialysis
Recruiting NCT03311321 - Vitamin K to Slow Progression of Cardiovascular Disease Risk in Hemodialysis Patients N/A
Recruiting NCT06098924 - HD Patients' Depression and Happiness
Recruiting NCT03419923 - Three Anticoagulation Strategies for Hemodialysis in Patients at Risk of Hemorrhage N/A