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Amiloride

Clinical trials are investigating Amiloride in people with lithium-treated bipolar disorder and in patients with autosomal dominant polycystic kidney disease. These studies look at whether Amiloride can improve urine concentration problems or affect arterial stiffness, and they measure both benefit and study safety in controlled settings.

Table of Contents

Trial overview

Two interventional studies investigated Amiloride in different patient groups.[1][2] Both studies were completed, and both used a comparison with placebo or another control treatment.[1][2]

Lithium-related urine concentration defect study

The first study, NCT05044611, was a Phase 2 randomized controlled trial called AMIND, which studied people treated with lithium carbonate for bipolar disorder for at least 5 years and who had a urine concentration defect.[1] The study asked whether Amiloride could reduce the urine concentration defect in patients who had nephrogenic diabetes insipidus, a condition where the kidneys cannot concentrate urine normally.[1]

This trial compared Amiloride with placebo and included oral Amiloride doses of 10 mg and 20 mg.[1] The study enrolled 148 participants and followed them for a 2-month treatment period.[1]

Autosomal Dominant Polycystic Kidney Disease study

The second study, NCT05228574, was a Phase 3 interventional trial called the Trampoline study in people with Autosomal Dominant Polycystic Kidney Disease.[2] The study tested whether Amiloride could change the effect of a high-salt diet on arterial stiffness and whether it could reduce arterial stiffness in both high-salt and low-salt settings.[2]

This trial compared Amiloride with control conditions that included potato starch placebo and sodium chloride supplementation.[2] It enrolled 54 participants and was completed.[2]

Main outcomes measured

In the lithium-related trial, the primary endpoint was the percentage change in maximal urine osmolality before and after the 2-month treatment period.[1] Urine osmolality is a measure of how concentrated the urine is, so this outcome shows whether the kidneys can hold on to water better after treatment.[1]

In the ADPKD trial, the primary outcomes were differences in pulse wave velocity between the high-salt and placebo groups, and before versus after Amiloride treatment in both groups.[2] Pulse wave velocity is a test used to estimate arterial stiffness, which means how rigid the arteries are.[2]

Study design and phases

Both studies were interventional, which means the researchers gave a treatment and then measured the results.[1][2] The lithium-related study was Phase 2, while the ADPKD study was Phase 3.[1][2]

These phases matter because Phase 2 studies often look for early signs that a treatment may work, while Phase 3 studies usually test the treatment in a larger group and compare results more broadly.[1][2]

Who participated

The lithium-related study focused on adults already treated with lithium carbonate for bipolar disorder for at least 5 years and with a urine concentration defect.[1] This means the study was not for all people with bipolar disorder, but for a specific group with kidney-related urine problems after long-term lithium use.[1]

The ADPKD study focused on people with autosomal dominant polycystic kidney disease.[2] The trial did not list extra participant details in the source data, but it clearly targeted this kidney disease group.[2]

Trial ID Phase Condition studied Status Enrollment
NCT05044611 Phase 2 Urine concentration defect in patients treated with lithium for bipolar disorder Completed 148
NCT05228574 Phase 3 Autosomal Dominant Polycystic Kidney Disease Completed 54

FAQ

  • What clinical conditions are being studied with Amiloride? The trials are studying urine concentration defects linked to long-term lithium treatment in bipolar disorder, and autosomal dominant polycystic kidney disease. These are two different patient groups with different research goals.
  • Who could take part in the Amiloride trials? One trial included patients treated with lithium carbonate for bipolar disorder for at least 5 years who had a urine concentration defect. Another trial included patients with autosomal dominant polycystic kidney disease.
  • What phases are the Amiloride trials? One study is Phase 2 and the other is Phase 3. Phase 2 usually looks at early evidence of benefit, while Phase 3 tests the treatment in a larger group.
  • What are the trials trying to measure? One trial measures the change in maximal urine osmolality, which shows how well the kidney can concentrate urine. The other trial measures pulse wave velocity, a test of arterial stiffness, before and after treatment.
  • Are these Amiloride studies still recruiting participants? Both trials listed here are completed. That means the study treatment and data collection have already ended.

Ongoing Clinical Trials on Amiloride

  • Study on Amiloride for Treating Nephrogenic Diabetes Insipidus in Bipolar Disorder Patients on Long-term Lithium Therapy

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study on the Effects of Amiloride and Sodium Chloride on Vascular Stiffness in Patients with Polycystic Kidney Disease

    Not recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

Glossary

  • Clinical trial: A research study in people that tests whether a treatment helps, is safe, or works better than a comparison group.
  • Interventional study: A study where researchers give a treatment or compare treatments and then measure the results.
  • Phase 2: A study stage that usually looks at whether a treatment shows early signs of benefit and continues to check safety.
  • Phase 3: A later study stage that tests a treatment in more people to better understand how well it works.
  • Enrollment: The number of people who joined the study.
  • Primary outcome: The main result the researchers plan to measure to answer the study question.
  • Urine osmolality: A measure of how concentrated the urine is. Higher values mean the kidneys are concentrating urine more strongly.
  • Nephrogenic diabetes insipidus: A condition where the kidneys do not respond normally, so the body cannot concentrate urine well.
  • Bipolar disorder: A mental health condition that causes strong changes in mood, energy, and activity.
  • Autosomal dominant polycystic kidney disease: A genetic kidney disease that causes many fluid-filled cysts to grow in the kidneys.
  • Pulse wave velocity: A test that measures how fast the blood pressure wave moves through the arteries. It is used as a sign of arterial stiffness.
  • Arterial stiffness: When the arteries are less flexible and more rigid than normal.

References