The CAP-KD trial is a prospective, multicenter, randomized, open-label, two-arm, parallel group comparison clinical trial and will be conducted as a researcher-directed study to assess the efficacy of Kremezin in preventing the progression of CKD. We compare two groups of patients: those receiving conventional treatment alone and those receiving such treatment paired with Kremezin.
Primary Outcome Measures:
- 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 Outcome Measures:
- Variation in urinary protein
- Changes in Creatinine Clearance
- Changes in health-related quality of life (HRQOL)
- Occurrence of adverse events
Estimated Enrollment: |
450 |
Study Start Date: |
April 2004 |
Study Completion Date: |
September 2007 |
A clinical trial to evaluate the efficacy of the oral carbonaceous adsorbent Kremezin in preventing the progression of chronic kidney disease (the Carbonaceous Oral Adsorbent's Effects on Progression of Chronic Kidney Disease [CAP-KD] trial) in predialysis patients. In the trial we are comparing two treatments: conventional treatment comprising an ACEI and/or ARB together with a low-protein diet, and combination treatment comprising the conventional treatment paired with Kremezin. Furthermore, we will compare the QOL in both groups of patients