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

October 17, 2007 updated by: Institute for Health Outcomes and Process Evaluation Reseach

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment

450

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan, 102-0072
        • iHope International

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Death
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)

Secondary Outcome Measures

Outcome Measure
Occurrence of adverse events
Variation in urinary protein
Changes in Creatinine Clearance
Changes in health-related quality of life (HRQOL)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute for Health Outcomes and Process Evaluation Reseach

Investigators

  • Study Chair: Yasushi Asano, Jichi Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

April 4, 2007

First Submitted That Met QC Criteria

April 4, 2007

First Posted (Estimate)

April 5, 2007

Study Record Updates

Last Update Posted (Estimate)

October 18, 2007

Last Update Submitted That Met QC Criteria

October 17, 2007

Last Verified

October 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAP-KD ver.3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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