Diet Modification for Chronic Kidney Disease

Overseen By Megan Stahl

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nand Wadhwa

Must be taking: Patiromer

Must not be taking: Other potassium agents

Disqualifiers: Patiromer allergy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 53

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether increasing fruit and vegetable intake, including those high in potassium, can be safe and beneficial for people with chronic kidney disease. Researchers aim to determine if a combination of dietary changes, specifically more fruits and vegetables, and a medication called patiromer can help manage potassium levels. It suits adults with chronic kidney disease who have recently experienced high potassium levels and are on certain medications. As an unphased trial, this study provides a unique opportunity to contribute to understanding dietary impacts on kidney health.

Will I have to stop taking my current medications?

The trial requires that if you are taking RASS inhibitors, beta-blockers, or diuretics, you must be on stable doses for 2 weeks. If you are taking other potassium controlling agents, you cannot participate in the trial.

What prior data suggests that this diet modification is safe for chronic kidney disease patients?

Research has shown that eating more fruits and vegetables benefits people with chronic kidney disease (CKD). One study found that consuming three to four servings daily lowered the risk of kidney failure by 25%. Another study demonstrated that this diet reduced kidney damage, as indicated by lower protein levels in urine.

However, monitoring potassium levels is crucial, especially for those with CKD. Some fruits and vegetables contain high potassium levels, which can be harmful if not managed well. To address this, the study uses patiromer, a medication that helps control potassium levels, making it safer for participants to consume more fruits and vegetables.

Overall, evidence suggests that a diet rich in fruits and vegetables is generally safe and well-tolerated for CKD patients when potassium is managed. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about increasing fruit and vegetable intake for chronic kidney disease (CKD) because it's a natural, non-pharmacological approach that could complement or even reduce the need for standard treatments like medications to control blood pressure or dialysis. Unlike traditional methods, this dietary change focuses on enhancing overall nutrition while maintaining safe potassium levels with the help of patiromer, a medication that helps manage potassium in the blood. This approach not only targets kidney health but also promotes better cardiovascular health and overall well-being, making it a holistic option for CKD patients.

What evidence suggests that increasing fruits and vegetables might be an effective treatment for chronic kidney disease?

Research shows that eating more fruits and vegetables benefits people with chronic kidney disease. This trial will evaluate the effects of increased fruit and vegetable consumption in these patients while maintaining normokalemia with patiromer. Studies have found that a diet rich in plant-based foods might lower the risk of kidney failure. For example, one study discovered that people who ate at least two servings of fruits and vegetables daily had a lower risk of kidney failure than those who ate less. Additionally, diets high in fruits and vegetables can improve a measure of kidney health called ACR in people with mild issues. Overall, these findings suggest that eating more fruits and vegetables supports kidney health. ^{1 3 4 5 6}

Who Is on the Research Team?

Nand Wadwha, MD

Principal Investigator

NY Health

Are You a Good Fit for This Trial?

This trial is for adults over 18 with chronic kidney disease (eGFR 15-44ml/min/1.73m2) and high potassium levels in their blood (≥5.0 mmol/L). They should be on stable doses of certain heart or blood pressure medicines for at least two weeks. People allergic to patiromer or already taking potassium controlling drugs can't join.

Inclusion Criteria

I am over 18 with chronic kidney disease and high potassium levels.

I have been on a stable dose of RASS inhibitors, beta-blockers, or diuretics for 2 weeks.

Diet evaluation for hyperkalemia (serum potassium ≥ 5.0) during the last 90 days

Exclusion Criteria

Patients with a known allergy to patiromer

I am currently taking medication to control my potassium levels.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Control Period

Participants document their normal daily consumption of fruits and vegetables in a food diary while taking Patiromer (Veltassa) daily

2 weeks

1 visit (in-person)

Dietary Intervention

Participants receive dietary/nutritional counseling and increase their fruit and vegetable intake, documenting choices in food diaries

50 weeks

Regular visits (in-person) up to 52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with continued use of Veltassa at the discretion of the investigator

up to 52 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Fruits and Vegetable increase

Trial Overview

The study tests if eating more fruits and vegetables, including those high in potassium, helps people with chronic kidney disease. It includes nutritional advice and managing high potassium levels using a drug called patiromer.

How Is the Trial Designed?

Group I: chronic kidney disease patients Experimental Treatment 1 Intervention

Evaluation of Increased fruits and vegetables consumption in chronic kidney disease patients maintaining normokalemia with patiromer

Who Is Running the Clinical Trial?

Nand Wadhwa

Lead Sponsor

Trials

1

Recruited

10+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10692733/

The Fruit and Veggies for Kidney Health Study

The present study supports that the F&V intervention with cooking instructions can effectively reduce ACR in individuals with lower ACR elevations, which are ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6855949/

Diet and Chronic Kidney Disease - PMC

Reducing animal protein intake and egg yolk and increasing intake of fruits and vegetables and fiber may prevent or delay end-stage renal disease.

3.

ajkd.org

ajkd.org/article/S0272-6386(23)00936-8/fulltext

Adherence to Plant-Based Diets and Risk of CKD ...

Studies have shown that generally healthy individuals who consume diets rich in plant foods have a lower risk of incident chronic kidney ...

4.

rrtjournal.biomedcentral.com

rrtjournal.biomedcentral.com/articles/10.1186/s41100-025-00668-x

Chronic kidney disease and diet - Renal Replacement Therapy

Conversely, some data suggest that the kidney prognosis is better with fruits and vegetables [55,56,57,58,59,60]. Of course, those with high ...

5.

archive.cdc.gov

archive.cdc.gov/www_cdc_gov/kidneydisease/publications-resources/fruits-vegetables-lowers-kidney-failure-risk.html

Eating Fruits and Vegetables Lowers Kidney Failure Risk

Eating Fruits and Vegetables Lowers Kidney Failure Risk · Less than 2 servings per day: 45% increased risk. · 2 to less than 3 servings per day: 40% increased ...

6.

kidney.org

kidney.org/subject/fruits-and-vegetables

Fruits and vegetables

Citrus fruits are superfoods high in vitamin C and pectin. Monitor potassium intake with CKD, consult your dietitian for safe citrus consumption. Diet and ...