CompletedNot Applicable

Dietary Acid Reduction and Progression of Chronic Kidney Disease

153 participantsStarted 1996-06-24

Plain-language summary

Upon completion, this project will determine if dietary acid reduction done with either fruits and vegetables (F+V) or the medication sodium bicarbonate (NaHCO3) in study participants with high blood pressure (hypertension) and initially normal kidney function but with signs of kidney injury 1) slows progression of chronic kidney disease (CKD); 2) improves indices of cardiovascular risk; and 3) better preserves acid-base status. These studies are designed to determine if the simple and comparatively inexpensive intervention of dietary acid reduction can prevent or reduce adverse outcomes in individuals with early-stage CKD.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Non-malignant high blood pressure or hypertension * 18-70 years old * Urine albumin-to-creatine ratio \> 200 mg/g creatinine * Estimated glomerular filtration rate (eGFR) greater than or equal to 90 ml/min/1.73 m2 * Serum total CO2 (TCO2) \> 22 mmol/l * Greater than or equal to 2 primary care visits in the preceding year * Able to provide informed consent Exclusion Criteria: * Malignant hypertension or history thereof * Primary kidney disease or findings consistent thereof such as \> 3 red blood cells per high powered field of urine or urine cellular casts * History of diabetes or fasting glucose greater than or equal to 110 mg/dl * History of hematologic disorders, malignancies, chronic infections, current pregnancy, history or clinical evidence of cardiovascular disease * Peripheral edema or diagnosis associated with edema such as heart/liver failure or nephrotic syndrome * Unable to provide consent

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Difference in estimated glomerular filtration rate (eGFR) at 5 years follow up

Timeframe: eGFR will be measured at baseline and yearly for 5 years.

Difference in the rate of eGFR change during 5 years follow up

Timeframe: eGFR will be measured at baseline and yearly for 5 years.

Difference in the net eGFR change during 5 years follow up

Timeframe: eGFR will be measured at baseline and yearly for 5 years.

Difference in change in urine albumin excretion during 5 years follow up

Timeframe: ACR will be measured at baseline and yearly for 5 years.

Difference in change in urine N-acetyl-D -glucosaminidase (NAG) excretion during 5 years follow up

Timeframe: NAG/creatinine will be measured at baseline and yearly for 5 years.

Difference in change in urine angiotensinogen (ATG) excretion during 5 years follow up

Timeframe: ATG/creatinine will be measured at baseline and yearly for 5 years.

Trial details

NCT IDNCT06046924

SponsorDonald Wesson

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2006-11-15

View on ClinicalTrials.gov More Chronic Kidney Diseases trials

Plain-language summary

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Difference in estimated glomerular filtration rate (eGFR) at 5 years follow up

Timeframe: eGFR will be measured at baseline and yearly for 5 years.

Difference in the rate of eGFR change during 5 years follow up

Timeframe: eGFR will be measured at baseline and yearly for 5 years.

Difference in the net eGFR change during 5 years follow up

Timeframe: eGFR will be measured at baseline and yearly for 5 years.

Difference in change in urine albumin excretion during 5 years follow up

Timeframe: ACR will be measured at baseline and yearly for 5 years.

Difference in change in urine N-acetyl-D -glucosaminidase (NAG) excretion during 5 years follow up

Timeframe: NAG/creatinine will be measured at baseline and yearly for 5 years.

Difference in change in urine angiotensinogen (ATG) excretion during 5 years follow up

Timeframe: ATG/creatinine will be measured at baseline and yearly for 5 years.