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Keto-/Amino Acid Supplemented Low Protein Diet in Patients With Chronic Kidney Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00364884
Recruitment Status : Unknown
Verified August 2006 by National Taiwan University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : August 16, 2006
Last Update Posted : August 16, 2006
Information provided by:
National Taiwan University Hospital

Brief Summary:
Keto-/amino acid supplemented low protein diet can reduce uremic symptoms, improve nutritional status, delay dialysis therapy and enhance health-related quality of life in our patients with stage V CKD in comparison to non-supplemented low protein diet.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Drug: ketoaminoacid Phase 4

Detailed Description:

Fifty patients will be included into the study. The study comprises 9 visits. The treatment period covers 6 months, preceded by a 2-week screening period and a 1 month run-in period. Patients are required to visit the investigator two times before the start of active treatment.

All patients who are qualified for this study will then be randomised by receiving their medication/introduction of dietary management using the standard simple randomization method.Group I patients will receive keto-/amino acid (Ketosteril) supplemented low protein diet during the active treatment period while Group II patients will receive non-supplemented low protein diet during the same period. The daily dose of keto-/amino acid for each Group I patient is one tablet every 5 kg body weight. The total daily dose will be divided into three times a day.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of the Effects Between Keto-/Amino Acid Supplemented Low Protein Diet and Non-Supplemented Low Protein Diet in Patients With Stage Ⅴ Chronic Kidney Disease
Study Start Date : August 2006
Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Primary Outcome Measures :
  1. Glomerular filtration rate (GFR) and creatinine clearance (Ccr)

Secondary Outcome Measures :
  1. 1. Hemodynamics, 2. Biochemistry status, 3. Bone density analysis, 4. Nutritional status, 5. Urinary status, 6. Compliance check, 7. Incidence of Aes8. Health-related quality of life, 9. Economic benefit

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 1. Serum creatinine ≧6 mg/dl at Visit 12. Creatinine clearance < 15 ml/min at Visit 13. Urine output ≧ 1,000 ml/day4. Primary renal disease: chronic glomerulonephritis or non-diabetic stage Ⅴ chronic kidney disease (confirmed by biopsy or clinical presentations/symptoms)5. Bilaterally reduced renal size shown by sonography6. Male or female patients aged 20 – 657. Ability of the patient to understand the basic implications of the study and to follow instructions8. Willingness to participate as indicated by a signed written informed consent

Exclusion Criteria:

  • 1. Severe arterial hypertension not responsive to medical therapy, maximum blood pressure values allowed: 180/100 mm Hg 2. Inadequate caloric intake due to extremely severe uremia (vomiting, anorexia, etc) 3. Malnutrition status with serum albumin level less than 3.5 g/dl in recent one month 4. Lack of adherence to dietary prescription 5. Water and sodium retention not responsive to diuretics 6. Clinical relevant severe cardiac disease, hepatic disorders (total bilirubin > 1.5 times the upper limit of normal), malabsorption disorders, diseases requiring steroids or non-steroid anti-inflammatory drugs 7. Severe sodium wasting syndrome that may affect renal function markedly and independently of dietary therapy 8. Concurrent use of nephrotoxic drugs 9. Severe infection with catabolic situation 10. Signs of uremic pericarditis 11. Symptoms of uremic polyneuropathy 12. Disorder of amino acid metabolism 13. Pregnant or nursing women 14. Participation in a clinical trial within the last 2 months 15. Former participation in the present study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00364884

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Contact: Kao Tze-Wah, MD, Master 886-2-23123456 ext 2919

Sponsors and Collaborators
National Taiwan University Hospital
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Principal Investigator: Kao Tze-Wah, MD, Master National Taiwan University Hospital

Layout table for additonal information Identifier: NCT00364884     History of Changes
Other Study ID Numbers: 941213
First Posted: August 16, 2006    Key Record Dates
Last Update Posted: August 16, 2006
Last Verified: August 2006

Keywords provided by National Taiwan University Hospital:
chronic kidney disease

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