| Trial ID: | L0390 |
| Source ID: | NCT00456859
|
| Associated Drug: |
Kremezin
|
| Title: |
Carbonaceous Oral Adsorbent's Effects on Progression of Chronic Kidney Disease
|
| Acronym: |
CAP-KD
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Kidney Failure, Chronic
|
| Interventions: |
DRUG: Kremezin
|
| Outcome Measures: |
Primary: The composite primary endpoint comprises the following events:|Doubling of serum Creatinine|Increase in serum Creatinine to 6.0 mg/dl or more|Endstage renal disease (ESRD; defined as that requiring dialysis or renal transplantation)|Death | Secondary: Variation in urinary protein|Changes in Creatinine Clearance|Changes in health-related quality of life (HRQOL)|Occurrence of adverse events
|
| Sponsor/Collaborators: |
Sponsor: Institute for Health Outcomes and Process Evaluation Reseach
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
450
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2004-04
|
| Completion Date: |
2007-09
|
| Results First Posted: |
|
| Last Update Posted: |
2007-10-18
|
| Locations: |
iHope International, Tokyo, 102-0072, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT00456859
|
