Chronic Kidney Disease Clinical Trial
Official title:
Effect of Dietary Sodium Reduction in Kidney Disease Patients With Albuminuria
The proposed randomized controlled trial will test the effect of dietary sodium reduction on albuminuria in patients with proteinuric chronic kidney disease. Results from this study will clarify the role of dietary sodium reduction in management of patients with proteinuric chronic kidney disease and its potential to halt the progression of chronic kidney disease.
Proteinuria is an early and sensitive marker of kidney damage and a risk factor for chronic kidney disease (CKD) progression, cardiovascular disease and all-cause mortality. Several cross-sectional epidemiological studies have reported an association between sodium intake and albuminuria (majority of proteinuria) that is independent of blood pressure (BP). In addition, a handful of small clinical trials have suggested a reduction in dietary sodium intake may decrease albuminuria in patients with CKD. The overall goal of this randomized controlled trial is to study the effect of dietary sodium reduction on albuminuria in CKD patients with albuminuria. A total of 150 participants with CKD and albuminuria will be recruited and randomly assigned to either a 24-week intensive behavioral modification program designed to reduce dietary sodium intake to 2,300 mg/day or to usual care in a 1:1 randomization ratio. The primary outcome will be the difference between the active intervention and control groups for change in urinary albumin-to-creatinine ratio from baseline to 24 weeks of follow-up. Urinary albumin-to-creatinine ratio will be assessed as the average of two 24-hour urine collections at each time point. Secondary outcomes will include estimated glomerular filtration rate (eGFR), BP, and number of antihypertensive medications. Urinary sodium excretion will be used to measure the success of the intervention. Racial differences in albuminuria changes due to reduction in dietary sodium intake will be analyzed. The intervention program will be modeled on best practices derived from the investigators prior experience in conducting sodium reduction behavioral interventions. The intervention program will address individual barriers to long-term sodium reduction and generate collective enthusiasm and motivation for adherence to the program. Study staff will receive training and direct support from a consultant with extensive experience in successful implementation of behavioral and dietary modification interventions. Results from this study will clarify the role of dietary sodium reduction in management of CKD patients with albuminuria and its potential to halt the progression of CKD, a global public health concern. The study will also explore the interaction of race/ethnicity with dietary sodium reduction on albuminuria in CKD patients. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05491642 -
A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses
|
Phase 1 | |
| Recruiting |
NCT06363097 -
Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease
|
||
| Terminated |
NCT04043026 -
The Effects of Renal Function and Atrial Fibrillation on Lipoproteins and Clot Structure/Function
|
||
| Completed |
NCT05318014 -
Low-protein Formula Supplements in Chronic Kidney Disease
|
N/A | |
| Active, not recruiting |
NCT06071065 -
Clinical Pharmacist Intervention on Medication Adherence and Clinical Outcomes in Chronic Kidney Disease Patients
|
N/A | |
| Completed |
NCT02878317 -
Skin Autofluorescence as a Risk Marker in People Receiving Dialysis.
|
||
| Not yet recruiting |
NCT06039254 -
Safety and Pharmacokinetics of HRS-1780 in Healthy Subjects and Subjects With Impaired Renal Function
|
Phase 1 | |
| Recruiting |
NCT03160326 -
The QUALITY Vets Project: Muscle Quality and Kidney Disease
|
||
| Completed |
NCT02756520 -
Observational Study on CKD Treatment With a Ketosteril Supplemented Protein-restricted Diet (Keto-024-CNI)
|
||
| Completed |
NCT02836574 -
A Study of Renal Autologous Cell Therapy (REACT) in Type 2 Diabetics With Chronic Kidney Disease
|
Phase 2 | |
| Completed |
NCT02875886 -
DD-study: Diet or Diuretics for Salt-sensitivity in Chronic Kidney Disease
|
Phase 4 | |
| Completed |
NCT02888171 -
Impact of Ferric Citrate vs Ferrous Sulfate on Iron Parameters and Hemoglobin in Individuals With CKD and Iron Deficiency
|
N/A | |
| Withdrawn |
NCT02885545 -
The Strategy to Prevent Hemorrhage Associated With Anticoagulation in Renal Disease Management (STOP HARM) Trial
|
Phase 4 | |
| Completed |
NCT02896309 -
The Effect of Correction of Metabolic Acidosis in CKD on Intrarenal RAS Activity
|
N/A | |
| Active, not recruiting |
NCT02483039 -
Nephrologist Follow-up Versus Usual Care After an Acute Kidney Injury Hospitalization
|
N/A | |
| Completed |
NCT02992548 -
Effect of Pravastatin on Erythrocyte Membrane Fatty Acid Contents in Patients With Chronic Kidney Disease
|
Phase 4 | |
| Terminated |
NCT02543177 -
Optimised Procedure in Patients With NSTEMI and CKD
|
N/A | |
| Completed |
NCT02369549 -
Micro-Particle Curcumin for the Treatment of Chronic Kidney Disease
|
Phase 3 | |
| Recruiting |
NCT02205944 -
Impact of Presurgical Exercise on Hemodialysis Fistula Outcomes
|
N/A | |
| Active, not recruiting |
NCT02231138 -
Efficacy and Safety of Abelmoschus Manihot for Chronic Kidney Disease
|
Phase 4 |