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

NCT00364884 | Unknown Phase 4

• 1 other identifier: 941213
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Kidney Disease

Keywords

chronic kidney disease

Outcome Measures

Primary Outcomes (1)

• Glomerular filtration rate (GFR) and creatinine clearance (Ccr)

Secondary Outcomes (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

Interventions

ketoaminoacid DRUG

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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

You may not qualify if:

• \. 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kao Tze-Wah, MD, Master

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kao Tze-Wah, MD, Master

CONTACT

886-2-23123456; twkao@ha.mc.ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 15, 2006
• First Posted: August 16, 2006
• Study Start: August 1, 2006
• Study Completion: August 1, 2007
• Last Updated: August 16, 2006

Record last verified: 2006-08