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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.
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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kremezin | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Variation in urinary protein | ||
| Changes in Creatinine Clearance | ||
| Changes in health-related quality of life (HRQOL) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yasushi Asano | Jichi Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| iHope International | Tokyo | 102-0072 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16189630 | Background | Morita S, Fukuhara S, Akizawa T, Asano Y, Kurokawa K. Study design and methods for a clinical trial of an oral carbonaceous adsorbent used to prevent the progression of chronic kidney disease (CAP-KD). Clin Exp Nephrol. 2005 Sep;9(3):219-27. doi: 10.1007/s10157-005-0358-7. | |
| 19615804 | Derived | Akizawa T, Asano Y, Morita S, Wakita T, Onishi Y, Fukuhara S, Gejyo F, Matsuo S, Yorioka N, Kurokawa K; CAP-KD Study Group. Effect of a carbonaceous oral adsorbent on the progression of CKD: a multicenter, randomized, controlled trial. Am J Kidney Dis. 2009 Sep;54(3):459-67. doi: 10.1053/j.ajkd.2009.05.011. Epub 2009 Jul 17. |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C040896 | AST 120 |
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| Occurrence of adverse events |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |