Carbonaceous Oral Adsorbent's Effects on Progression of Chronic Kidney Disease (CAP-KD)

This study has been completed.
Sponsor:
Information provided by:
Institute for Health Outcomes and Process Evaluation Reseach
ClinicalTrials.gov Identifier:
NCT00456859
First received: April 4, 2007
Last updated: October 17, 2007
Last verified: October 2007
  Purpose

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.


Condition Intervention Phase
Kidney Failure, Chronic
Drug: Kremezin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Carbonaceous Oral Adsorbent's Effects on Progression of Chronic Kidney Disease (CAP-KD)

Resource links provided by NLM:


Further study details as provided by Institute for Health Outcomes and Process Evaluation Reseach:

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
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The subject is an outpatient.
  • The subject is 20 years of age or older at the time of consent to participate in the study.
  • The subject's serum creatinine value is 5.0 mg/dl or less at the time of case registration.
  • The inverse serum creatinine value, calculated using measurements at four or more time points during an observation period that occurs within 48 weeks of case registration, is decreasing, on average, according to linear-regression analysis performed at the case registration center.
  • The subject's blood pressure is well controlled before the initial serum creatinine measurement during the observation period.
  • The subject has been treated with an ACEI and/or ARB before the initial serum creatinine measurement during the observation period.
  • The subject has undergone low-protein diet therapy (> 0.8 g/kg per day) before the initial serum creatinine measurement during the observation period.
  • The subject has not changed the type or dose of medication for renal failure for 4 weeks prior to case registration.
  • The subject has participated in thorough consultation and has been informed as to the purpose, description, expected adverse effects, and risks of this study according to the consent form, and has voluntarily signed the informed consent form.

Exclusion Criteria:

  • The subject has a passage disorder of the gastrointestinal tract.
  • The subject has been treated with Kremezin within the period from the initial measurement of the serum creatinine level prior to case registration to the time of study commencement.
  • The subject has rapid progressive glomerular nephritis, hydronephrosis, occlusive urinary tract injury, drug-induced nephropathy, or transplanted kidney.
  • The subject has complications such as severe hepatopathy, liver cirrhosis, severe infection, class III or above New York Heart Association (NYHA) congestive heart failure, severe arrhythmia, or unstable angina.
  • The subject has had cardiac infarction, cerebral infarction, or cerebral hemorrhage within the past 6 months.
  • The subject presents with severe nephrotic syndrome (serum albumin < 2 g/dl).
  • The subject is currently pregnant, or plans to become pregnant during the study period.
  • The subject abuses alcohol.
  • The subject has a body weight less than 80% or more than 160% of the standard weight {[height(m)]^2 x 22}.
  • The subject has significant difficulty in controlling his/her blood sugar level within 3 months of case registration (hemoglobin [Hb]A1c > 8.0% on one occasion).
  • The subject has a progressive malignant tumor.
  • The subject is not available for study visits at least once per 2 months to provide urine samples.
  • The subject is inappropriate for participation in the study for other reasons, as determined by an investigator.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00456859

Locations
Japan
iHope International
Tokyo, Japan, 102-0072
Sponsors and Collaborators
Institute for Health Outcomes and Process Evaluation Reseach
Investigators
Study Chair: Yasushi Asano Jichi Medical University
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00456859     History of Changes
Other Study ID Numbers: CAP-KD ver.3
Study First Received: April 4, 2007
Last Updated: October 17, 2007
Health Authority: Japan: Institutional Review Board

Keywords provided by Institute for Health Outcomes and Process Evaluation Reseach:
chronic kidney disease
oral carbonaceous adsorbent
randomized clinical trial
composite endpoint

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Urologic Diseases

ClinicalTrials.gov processed this record on September 14, 2014