Renal failure due to long-term use of lithium salts in patients with bipolar disorders. MedDRA version: 9.1 Level: HLT Classification code 10004938 Term: Bipolar disorders MedDRA version: 9.1 Level: LLT Classification code 10009121 Term: Chronic renal failure worsened
Conditions
Interventions
Trade Name: Modamide
Product Name: amiloride (modamide)
Pharmaceutical Form: Tablet
INN or Proposed INN: AMILORIDE (Modamide)
CAS Number: 2016-88-8
Current Sponsor code: not available
Other descripti
Sponsors
Parnassia-BAVO groep
St. Elisabeth Ziekenhuis
University Medical Center Utrecht
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: patients with either hyper or hypotension. Use of antihypertensive medication is allowed. not being able to provide informed consent for participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: determining the effect on kidney functioning of addition of amiloride to continuing lithium treatment in patients with lithium induced renal failure. ;Secondary Objective: Comparing the effect of addition of amiloride treatment to continuing lithium treatment with discontinuation of lithium treatment in patients with renal failure;Primary end point(s): a decrease in renal faillure defined as a decrease in plasma creatinine level of at least 50% in nine months. Creatinine clearance (estimated by using MDRD), lithium serum level, blood pressure and potasium levels will be monitored with three month intervals during a two year follow-up period. In addition patients` psychiatric condition will be evaluated. | — |
Countries
Netherlands
Outcome results
None listed