Study to compare the efficacy of diuretics in patients in hemodialysis with residual diuresis

Single center randomized clinical study to compare the efficacy of diuretics in patients in hemodialysis with residual renal function

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-003214-41-ES

Enrollment

Registered

2013-09-16

Start date

2013-11-11

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic renal disease stage V in hemodialysis MedDRA version: 16.0 Level: LLT Classification code 10051051 Term: Renal disease System Organ Class: 100000004857

Interventions

Pharmaceutical Form: Tablet INN or Proposed INN: FUROSEMIDE CAS Number: 54-31-9 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40- Pharmaceutical Form: Tablet INN

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients older than 18 years of age. Patients with chronic renal disease in stage V in Hemodialysis. Patients that keep a residual renal function (diuresis equal or greater than 200 ml per day. Patients who have been in hemodialysis for at least 3 months at the time of inclusion in the study. Patients giving informed consent to participate in the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 16 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: Patients in hemodialysis with plasma K concentrations lower than 4 mEq/L during the inter HD period in short days. Patients in HD requiring K suplements in the dialysis. Patients with inter HD weight gain in long days lower than 1 kg. Patients with history of adverse events or hypersensibility to the study treatments. Patients not giving informed consent to participate in the study. Pregnant women or nursing mothers. Patients with contraindications to the administration of any of the study diuretics or to the concomitant administraion of both drugs, according to the SPCs. Patients that the investigator in charge of the medical care considers the participation in the study would be detrimental.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the effect of combined use of furosemide and hydrochlorothiazide on interdialysis weight gain in patients in HD with residual renal function;Secondary Objective: To assess the effects of combined use of furosemide and hydrochlorothiazide on the following parameters: Diuresis REduccion of ultrafiltrate in short and long days inter HD Dry weight Blood pressure in short and long and long days inter HD Plasma K concentration in short inter HD days Na, K and Cl in urine in short inter HD days Hipotension, cramps and gout episodes Use of hipotensive drugs HCO3 and uric acid plasma concentration in short HD days Creatinine and urine clearance Use of K supplements in HD To assess the safety of the administraion of furosemide and hydroclorotiazide in this patient population;Primary end point(s): Inter HD weight gain in long days at the end of each period;Timepoint(s) of evaluation of this end point: 4 weeks	—

Measure

Time frame

Main Objective: To assess the effect of combined use of furosemide and hydrochlorothiazide on interdialysis weight gain in patients in HD with residual renal function;Secondary Objective: To assess the effects of combined use of furosemide and hydrochlorothiazide on the following parameters: Diuresis REduccion of ultrafiltrate in short and long days inter HD Dry weight Blood pressure in short and long and long days inter HD Plasma K concentration in short inter HD days Na, K and Cl in urine in short inter HD days Hipotension, cramps and gout episodes Use of hipotensive drugs HCO3 and uric acid plasma concentration in short HD days Creatinine and urine clearance Use of K supplements in HD To assess the safety of the administraion of furosemide and hydroclorotiazide in this patient population;Primary end point(s): Inter HD weight gain in long days at the end of each period;Timepoint(s) of evaluation of this end point: 4 weeks

—

Secondary

Measure	Time frame
Secondary end point(s): Difference between diuresis at baseline and at the end of each study treatment;Timepoint(s) of evaluation of this end point: 4 weeks	—

Countries

Spain

Contacts

Public ContactOficina de Recerca

Fundació Parc Taulí

afarre@tauli.cat

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026