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Lumasiran in Hyperoxalaemic Patients on Haemodialysis

NCT06225544 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-08-21

No results posted yet for this study

Summary

This study will look at how well a drug that reduced the amount of oxalate in the body works in patients that have kidney disease and need dialysis treatment. People with kidney disease often have higher levels of oxalate in the blood. People with kidney disease are also at higher risk of having heart attacks, heart disease and strokes (these are called cardiovascular diseases). It is thought that high oxalate levels may increase the risk of these diseases. This study will investigate if this medicine can lower the amount of oxalate in the blood of dialysis patients and see if there is any change in the health of their heart. This medicine is already used for people who have high oxalate levels because of a genetic cause and has been used safely for patients on dialysis.

The study will put the participants randomly into either the group getting the study medicine or the group getting a placebo (this will be a solution of saline water). Neither participants not the doctors will know whether the drug or placebo is given until after the end of the study.

At the start of the study all the participants will have an echocardiogram (an ultrasound of the heart) and again 6 months later at the end of the study. We will also take blood tests once a month when the participants come for dialysis.

Conditions

  • Haemodialysis
  • Chronic Kidney Disease Requiring Chronic Dialysis
  • Cardiovascular Disease
  • Cardiovascular Risk Factor
  • Hyperoxalemia

Interventions

DRUG

Lumasiran

Subcutaneous injection, given as three monthly loading doses followed by one further maintenance dose.

DRUG

0.9% Sodium Chloride (placebo)

Placebo, subcutaneous injection, given as three monthly loading doses followed by one further maintenance dose.

Sponsors & Collaborators

Principal Investigators

  • Felix Knauf, MD · Charite Universitätsmedizin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-14
Primary Completion
2025-01-30
Completion
2025-03-01

Countries

  • Germany

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06225544 on ClinicalTrials.gov