Declination of Glomerular Infiltration Rate in Chronic Kidney Disease Population Clinical Trial
Official title:
Effect of Intensive Low Sodium Restriction on Glomerular Infiltration Rate in Chronic Kidney Disease
| Verified date | August 2015 |
| Source | Ramathibodi Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Thailand: Ethical Committee |
| Study type | Interventional |
Introduction :
Due to Chronic kidney disease is a public health problem, which is important increased in
both developed and developing countries . And sodium intake restriction was related to the
reduction of blood pressure and urine protein which is one of the important risk factor in
chronic kidney disease. One of the problem in sodium restriction failure in Thai population
with CKD nowadays is lack of knowledge and problem unawareness.
The study hypothesis :
Intense knowledge about sodium reduction and immediate feedback of the sodium intake could
be simultaneously modifying the behavior to reduce sodium intake , blood pressure and also
GFR reduction rate
Objectives :
To compare the effect of dietary salt restriction on glomerular filtration rate (GFR)
between CKD patients receiving strict controlled combined with immediate individual feedback
(DISC Progrram) and those receiving standard education.
Study design :
Multicenter, open labeled, parallel, randomized controlled trial
Sample size : 600
Primary outcome : GFR reduction (CKD-EPI)
Secondary outcome :
- Achievement rate of Na intake < 2 g/day (Urine Na < 90 mEq/day)
- Blood pressure difference
- Proportions of patients with BP reached the target (130/80 mmHg)
- Number of anti-hypertensive drugs use to achieve BP target
- Urine albumin/creatinine ratio
- Major Adverse Cardiac Events (MACE)
- Cardio-ankle vascular index (CAVI)
- ankle-brachial index (ABI)
Documentary Proof of Ethical Clearance :
This project has been reviewed and approved by the Comittee on Human Rights Related to
Research Involving Human Subjects , based on the declaration of Helsinki
| Status | Enrolling by invitation |
| Enrollment | 600 |
| Est. completion date | August 2016 |
| Est. primary completion date | August 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - CKD stage 3-4 (eGFR 15-59 mL/min/1.73m²) - Microalbuminuria - Any blood pressure level Exclusion Criteria: - Salt - losing conditions - Hyponatremia (Na < 135 mg/dL) or Hypernatremia (Na > 145 mg/dL) - Bilateral renal artery stenosis - Severe comorbid disease or life expectancy <1 year (severe cardiovascular disease, chronic liver disease, severe infection , malignancy) - Immunosuppressant used |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| PANTHITA SORNHIRAN |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The declination of glomerular infiltration rate | one year | Yes |