AMIloride for the Treatment of Nephrogenic Diabetes Insipidus for Patients with Bipolar Disorder Treated with Lithium

• Register: ClinicalTrials.gov
• Last refreshed on: 27 January 2025
• Main ID: NCT05044611
• Date of registration: 27/08/2021
• Prospective Registration: Yes
• Primary sponsor: Assistance Publique - Hôpitaux de Paris
• Public title: AMIloride for the Treatment of Nephrogenic Diabetes Insipidus for Patients with Bipolar Disorder Treated with Lithium AMIND
• Scientific title: AMIloride for the Treatment of Nephrogenic Diabetes Insipidus for Patients with Bipolar Disorder Treated with Lithium: a Randomized Controlled Trial
• Date of first enrolment: January 11, 2023
• Target sample size: 148
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT05044611
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

France

Contacts

• Name: DECHANET Aline, Mrs
• Affiliation: Assistance Publique - Hôpitaux de Paris (AP-HP)

Key inclusion & exclusion criteria

Inclusion Criteria:

- Adults between 18 and 70 years (age = 18 years and <70 years)

- Patient with bipolar disorder

- Patient treated with lithium for at least 5 years

- Patient with a urine concentration defect defined by a maximal urine osmolality <
600 mOsm/kg

- Woman of childbearing age agreeing to use an efficient contraceptive method for 12
months

Exclusion Criteria:

- Renal failure defined as eGFR < 30 ml/min/1.73m² estimated by the CKD-EPI equation

- Kalemia > 5 mmol/l

- Hypersensitivity or known allergy to amiloride

- Hypersensitivity to lactose

- Known adrenal insufficiency

- Concomitant use of other potassium-sparing treatment (e.g. spironolactone,
angiotensin converting enzyme inhibitors (ACE), angiotensin II receptor (AT2R)
antagonists, calcineurin inhibitors tacrolimus and ciclosporin)

- Acute ongoing infection (less than 3 days before inclusion)

- Severe heart failure (NYHA > II)

- Rhythm, conduction or repolarisation disorder present on an ECG done within 12
months prior to inclusion

- Acute phase of mood disorder

- Uncontrolled diabetes mellitus or diabetes with hyporeninism hypoaldosteronism

- Potassium supplements

- Use of heparins

- Use of trimethoprim

- Cirrhosis

- Oedemas

- Previous use of amiloride use in the 6 months prior to randomisation)

- Pregnant or breastfeeding women

- Participation in another clinical study involving investigational medicinal product
or patient being in the exclusion period at the end of a previous study

- Patient refusal to participate

- Non-affiliation to a social security regimen or CMU

- Patient under State Medical Aid

- Subject deprived of freedom, subject under a legal protective measure


Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Bipolar Disorder

Intervention(s)

Drug: Anhydrous Amiloride Hydrochloride

Drug: Placebo

Primary Outcome(s)

The main objective of this study is demonstrating the efficacy of amiloride to reduce the urine concentration defect in patients treated by lithium and presenting a nephrogenic diabetes insipidus after 2 months of treatment. [Time Frame: 2 month after randomization]

Secondary Outcome(s)

Demonstrate the efficacy of amiloride to reduce polyuria [Time Frame: 2 months after randomization and 12 months after randomization]

Evaluate the effect of amiloride in circulating lithium levels stability [Time Frame: 2 months after randomization]

Evaluate the effect of amiloride in mood stability [Time Frame: 12 months after randomization]

Demonstrate the efficacy of amiloride to increase quality of life [Time Frame: 2 months after randomization and 12 months after randomization]

Demonstrate the efficacy of amiloride to reduce the sensation of thirst [Time Frame: 2 months after randomization and 12 months after randomization]

Demonstrate the efficacy of amiloride to reduce the decline of eGFR after one year of treatment [Time Frame: 12 months after randomization]

Demonstrate the efficacy of amiloride to reduce nocturia [Time Frame: 2 months after randomization and 12 months after randomization]

Evaluate the effect of amiloride in mood stability [Time Frame: 2 months after randomization and 12 months after randomization]

Secondary ID(s)

APHP200042

Source(s) of Monetary Support

Please refer to primary and secondary sponsors