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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2006 by National Taiwan University Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00364884
First received: August 15, 2006
Last updated: NA
Last verified: August 2006
History: No changes posted
  Purpose

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 Intervention Phase
Chronic Kidney Disease
 Drug: ketoaminoacid
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 50
Study Start Date: August 2006
Estimated Study Completion Date: August 2007
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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00364884

Contacts
Contact: Kao Tze-Wah, MD, Master 886-2-23123456 ext 2919 twkao@ha.mc.ntu.edu.tw

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

No publications provided

ClinicalTrials.gov Identifier: NCT00364884     History of Changes
Other Study ID Numbers: 941213
Study First Received: August 15, 2006
Last Updated: August 15, 2006
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
chronic kidney disease

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

ClinicalTrials.gov processed this record on May 23, 2013