BridgeMD
New treatment option for Chronic Kidney Diseases
Official title Effect of a Specialized Oral Supplement on Nutritional Status and Quality of Life in Non-dialysis CKD
ClinicalTrials.gov ID: NCT06576479
What this study is testing
- What it's testing
- Patients whit chronic kidney disease (CKD) there is a high prevalence of nutritional disorders and negative changes in body composition, which is strongly associated with an increased risk of morbidity and mortality.
- 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 18 to 90
You may be able to join if
- Patients over 18 years of age
- Patients with diabetic kidney with eGFR \<60 ml / min / 1.73m2 and ≥15 ml / min / 1.73m2, (stage G3a, G3b and G4 respectively)
- Patients with protein energy expenditure (defined by serum albumin \< 3.8 g/dl)
- Patients with protein energy expenditure (defined by 24-hour recall less than a dietary protein intake \<0.6 g/kg/d or have a consumption \<25...
- Patients who can read and write (or primary caregiver)
You likely can't join if
- Previous hospitalizations in the last month
- Patients with serious complications (chronic infection, septicemia, cancer, HIV, Alzheimer's, uncontrolled heart failure, liver failure...
- Patients with actual consumption of food supplements and / or keto analogues. Elimination Criteria:
- Failure to attend nutritional assessment and biochemical testing at baseline, 2 months, and end of the study.
- Failure to take the supplement \>10% (\>12 failed doses).
- Diagnosis of any comorbidity during the intervention period.
See the full eligibility criteria
- Patients over 18 years of age
- Patients with diabetic kidney with eGFR \<60 ml / min / 1.73m2 and ≥15 ml / min / 1.73m2, (stage G3a, G3b and G4 respectively)
- Patients with protein energy expenditure (defined by serum albumin \< 3.8 g/dl)
- Patients with protein energy expenditure (defined by 24-hour recall less than a dietary protein intake \<0.6 g/kg/d or have a consumption \<25 kcal/kg/d
- Patients who can read and write (or primary caregiver)
- Domicile within the metropolitan area
- Previous hospitalizations in the last month
- Patients with serious complications (chronic infection, septicemia, cancer, HIV, Alzheimer's, uncontrolled heart failure, liver failure, cerebrovascular syndrome, malabsorption syndrome, or allergy to any ingredient in...
- Patients with actual consumption of food supplements and / or keto analogues. Elimination Criteria:
- Failure to attend nutritional assessment and biochemical testing at baseline, 2 months, and end of the study.
- Failure to take the supplement \>10% (\>12 failed doses).
- Diagnosis of any comorbidity during the intervention period.
- Initiation of replacement therapy.
- Identification of adverse effects.
- Withdrawal of voluntary participation by the patient.
- Death.
The study team makes the final eligibility decision.
Where it's taking place
- Guadalajara, Jalisco, Mexico
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, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guadalajara, Jalisco, Mexico. 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.