Effect of amiloride on lithium-induced chronic nephropathy.Comparing discontinuation of lithium treatment to adding amiloride while continuing lithium treatment.
- Conditions
- Renal failure due to long-term use of lithium salts in patients with bipolar disorders.MedDRA version: 9.1Level: HLTClassification code 10004938Term: Bipolar disordersMedDRA version: 9.1Level: LLTClassification code 10009121Term: Chronic renal failure worsened
- Registration Number
- EUCTR2008-004746-81-NL
- Lead Sponsor
- Parnassia-BAVO groep
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Patients are eliglible for participation in case of
Long-term use of lithium treatment, defined as having used lithium for at least five years prior to inclusion.
progressive renal faillure defined as an increase of plasma creatinine levels of at least 10umol/l/year for at least five years. with r2 >/= 0.85 and a maximal serum creatinine level of 200umol/L.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
patients with either hyper or hypotension. Use of antihypertensive medication is allowed.
not being able to provide informed consent for participation
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method