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New treatment option for Chronic Kidney Disease Stage 3
Official title Effects of Replacing High Protein Foods in People With Chronic Kidney Disease
ClinicalTrials.gov ID: NCT07105670
What this study is testing
- What it's testing
- The goal of this crossover clinical trial is to explore the effects of red meat intake on serum and fractional urinary excretion of uremic toxins including trimethylamine N-oxide in people with chronic kidney disease.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 70
You may be able to join if
- Age 40-70 years
- Male or postmenopausal female
- Stage 3 CKD (eGFR between 30-59ml/min/1.73m\^2 by the CKD-EPI equation (without race correction)).
- If eGFR is greater than or equal to 45ml/min/1.73m\^2 then albuminuria must be greater than 300mg/g creatinine by spot urine.
- Willing to consume controlled diet for duration of the study
You likely can't join if
- Hemoglobin A1c greater than 7% within previous six months
- Treatment with metformin or insulin within previous three months
- Blood pressure greater than 150/100 mmHg from chart of home on at least two occasions in prior month (can be inclusive of screening visit)
- Change in cardiovascular and/or hypertension medication in the last 30 days
- History of major gastrointestinal disease (e.g. inflammatory bowel disease, uncontrolled irritable bowel syndrome, C. difficile chronic infection...
- Known HIV disease
See the full eligibility criteria
- Age 40-70 years
- Male or postmenopausal female
- Stage 3 CKD (eGFR between 30-59ml/min/1.73m\^2 by the CKD-EPI equation (without race correction)).
- If eGFR is greater than or equal to 45ml/min/1.73m\^2 then albuminuria must be greater than 300mg/g creatinine by spot urine.
- Willing to consume controlled diet for duration of the study
- Willing to collect fecal samples at home
- Hemoglobin A1c greater than 7% within previous six months
- Treatment with metformin or insulin within previous three months
- Blood pressure greater than 150/100 mmHg from chart of home on at least two occasions in prior month (can be inclusive of screening visit)
- Change in cardiovascular and/or hypertension medication in the last 30 days
- History of major gastrointestinal disease (e.g. inflammatory bowel disease, uncontrolled irritable bowel syndrome, C. difficile chronic infection, celiac disease, diverticulitis, stomach or duodenal ulcers)
- Known HIV disease
- Hospitalization in the last two months
- Significant recent unintentional weight loss (5% of weight over past three months)
- Cancer or received cancer treatment in the last year (except basal cell carcinoma)
- Prior bariatric surgery (i.e. gastric bypass, sleeve gastrectomy) or restrictive bariatric surgery (i.e. adjustable gastric band)
- Treatment with immunosuppressive medications in the past six months or more than one week of treatment with prednisone greater than 10mg per day in the past three months (or equivalent steroid dose of non-prednisone...
- Recent antibiotic use defined as a single course of antibiotics within the past three months or two or more courses within the past six months
- Known food allergy that would influence the ability to consume the study diets
- History of hyperkalemia defined as greater than 5.5mmol/L on at least two occasions
- Other medical conditions or concerns at the discretion of the investigators
The study team makes the final eligibility decision.
Where it's taking place
- West Lafayette, Indiana, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include West Lafayette, Indiana, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.