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Not Yet RecruitingPhase 2ACTRN12623000980639

Efficacy of Angiotensin II in Cramp Reduction for Maintenance Patients on HaemoDialysis

Efficacy of Angiotensin II in Cramp Reduction for Kidney Failure Patients on Maintenance HaemoDialysis

Sponsor

Rinaldo Bellomo

Enrollment

16 participants

Start Date

Oct 1, 2023

Study Type

Interventional

Conditions

Painful muscle cramps

Summary

Skeletal muscle cramping is a common and bothersome symptom for patients on maintenance dialysis therapy. Although initially considered to be an intradialytic phenomenon associated with rapid fluid removal during haemodialysis, accumulating evidence indicates that dysfunction of the renin-angiotensin-aldosterone system (RAAS) may play a significant role in its pathophysiology. This is a multicentre, phase 2, placebo-controlled, randomised crossover trial of the safety, tolerability, and efficacy of angiotensin II in chronic haemodialysis patients who regularly experience cramps. We hypothesise that angiotensin II will be safe, feasible, and effective at reducing cramping.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria7

  • Adults aged at least 18 years
  • Chronic haemodialysis for kidney failure (i.e. 3 times per week)
  • Recent history of painful muscle cramps defined by:
  • 1 Early termination of a dialysis session due to muscle cramps in the previous month
  • 2 Reduction in prescribed ultrafiltration or administration of fluid due to muscle cramps in the previous month
  • Arteriovenous fistula, graft or permacath in situ
  • Informed consent provided by the patient or medical treatment decision maker

Exclusion Criteria6

  • Known or suspected allergy to components of angiotensin II
  • Presently taking an angiotensin II receptor blocker
  • Previous intra-cerebral haemorrhage
  • Pre-dialysis hypertension (SBP >180 mmHg)
  • Severe heart failure (LVEF <20%)
  • Any other disease or clinically significant abnormality in laboratory parameters that, according to the investigator, might compromise the safety of the subject or interfere with participation in the trial or compromise the trial objective

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Interventions

Infusion of 2.5mg angiotensin II in 500mL normal saline (concentration 5000 ng/mL) titrated between 0.1 and 30 ng/kg/min and administered during the first haemodialysis session of the week for two of

Infusion of 2.5mg angiotensin II in 500mL normal saline (concentration 5000 ng/mL) titrated between 0.1 and 30 ng/kg/min and administered during the first haemodialysis session of the week for two of four weeks. The remaining two haemodialysis treatments will function as the 'wash out' period.

Locations(2)

Austin Health - Austin Hospital - Heidelberg

VIC, Australia

Royal Melbourne Hospital - City campus - Parkville

VIC, Australia

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ACTRN12623000980639