E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Renal failure due to long-term use of lithium salts in patients with bipolar disorders. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10004938 |
E.1.2 | Term | Bipolar disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10009121 |
E.1.2 | Term | Chronic renal failure worsened |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
determining the effect on kidney functioning of addition of amiloride to continuing lithium treatment in patients with lithium induced renal failure.
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E.2.2 | Secondary objectives of the trial |
Comparing the effect of addition of amiloride treatment to continuing lithium treatment with discontinuation of lithium treatment in patients with renal failure |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal exclusion criteria |
patients with either hyper or hypotension. Use of antihypertensive medication is allowed. not being able to provide informed consent for participation
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Group 1 stops lithium (control), group 2 continues lithium with amiloride added |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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After cessation of lithium-use, or amiloride-addition in continued use of lithium, the plasma-creatinin concentration will be measured at quarterly intervals. In group II patients will cease using lithium (and amiloride) if no change is visible in the course of the plasma creatinin concentration (at least cutting in half the slope of the plasma creatinine concentration) within 9 months. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |