Efficacy of Diuretics in Kidney Disease

Stanford University

Status and phase: Terminated; Phase 2

Conditions: Chronic Kidney Disease; End Stage Renal Disease

Treatments: Drug: Metolazone; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04542304

56566

Details and patient eligibility

About

This study will determine the efficacy of diuretics in patients with chronic kidney disease.

Full description

Participants with chronic kidney disease will undergo two 1-week study periods (single-dose diuretic versus single-dose placebo) separated by 1-2 weeks of washout in a cross-over design. Blood and urine samples will be collected at the end of each study period to determine the effect on urine output and to assess the kidney clearance and levels of uremic solute. Participants will weigh themselves daily.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• stable chronic kidney disease patients able to provide consent
• stable dialysis patients who produce urine and able to provide consent

Exclusion criteria

• use of antibiotics for last two months or expected antibiotic use
• recent hospitalization or other event resulting in instability of food intake

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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17 participants in 2 patient groups, including a placebo group

Metolazone then placebo

Active Comparator group

Description:

Metolazone will be taken orally during the first week, followed by washout of 1-2 weeks, then placebo will be taken the following week.

Treatment:

Drug: Placebo

Drug: Metolazone

Placebo then Metolazone

Placebo Comparator group

Description:

Placebo will be taken orally during the first week, followed by washout of 1-2 weeks, then metolazone will be taken the following week.

Treatment:

Drug: Placebo

Drug: Metolazone