E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Metabolic acidosis in chronic kidney disease |
Metabole acidose bij chronische nierinsufficientie |
|
E.1.1.1 | Medical condition in easily understood language |
High blood acidity in patients with chronic kidney disease |
verhoogde zuurgraad van het bloed bij mensen met een chronische nierziekte |
|
E.1.1.2 | Therapeutic area | Body processes [G] - Physiological processes [G07] |
MedDRA Classification |
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 |
To study if sodiumbicarbonate therapy diminishes activity of the intrarenal renin-angiotensin-system (RAS) without affecting the systemic RAS, i.e. the intrarenal RAS can be inhibited by oral alkali in CKD patients with metabolic acidosis. |
Om te bestuderen of natriumbicarbonaat de activiteit van het intrarenale renine-angiotensine-systeem vermindert, zonder het systemische RAS te beinvloeden. In andere woorden: het intrarenale RAS kan worden geremd door orale alkali in patienten met chronische nierschade en metabole acidose. |
|
E.2.2 | Secondary objectives of the trial |
- To study if sodium bicarbonate therapy in patients with metabolic acidosis due to chronic kidney disease effects kidney damage markers. - To study whether or not there is a difference in alteration of levels of RAS components in response to sodium bicarbonate therapy in patients with metabolic acidosis due to chronic kidney disease treated with AT-1 receptor blockade and without. |
- te bekijken of sodiumbicarbonaat therapie in patienten met metabole acidose als gevolg van chronische nierinsufficientie nierschade-markers beinvloed. - te bestuderen of er een verschil is in verandering van RAS componenten na natriumbicarbonaat bij patienten met metabole acidose als gevolg van chronische nierinsufficientie, die behandeld worden met een AT-1 receptor blokker en patienten die hier niet mee behandeld worden |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- male or female adult (>18 years) - chronic kidney disease stage 4, i.e. eGFR (MDRD) 15-30 ml/min - plasma bicarbonate concentration of <24 and >15 meq/L, the latter because in that case it seems highly recommended to start sodiumbicarbonate suppletion and not to postpone this |
- volwassen man/vrouw (ouder dan 18 jaar) - chronische nierinsufficientie, stadium 4, m.a.w. eGFR (MDRD) 15-30 ml/min - plasma bicarbonaat concentratie onder de 24 en boven de 15 mmol/L, het laatste omdat het onder de 15 aan te raden is het starten van natriumbicarbonaat therapie niet uit te stellen |
|
E.4 | Principal exclusion criteria |
- plasma bicarbonate level >24 meq/L or <15 meq/L - sodiumbicarbonate use in the 1 month preceeding the study - a kidney transplant in situ - heart failure - liver cirrhosis - resistant hypertension (blood pressure >140/90 mmHg despite the use of 3 or more different antihypertensives - a history of inadherence to medication - use of calcineurin inhibitors (these immunosuppressive drugs are known to induce metabolic acidosis and influence electrolytes and acidbase balance) |
- een plasma bicarbonaat groter dan 24mmol/L of kleiner dan 15 mmol/L - natriumbicarbonaat gebruik in de maand voor de studie - een niertransplantaat in situ - hartfalen - levercirrose - therapieresistente hypertensie (bloeddruk >140/90 ondanks 3 of meer verschillende antihypertensiva - een voorgeschiedenis van medicatieontrouw - gebruik van calcineurine remmers (deze immunosuppresieve middelen kunnen metabole acidose induceren en beinvloeden electrolyten en zuurbase balans) |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Study ends after 4 weeks (in which the patient recieved Sodium Bicarbonate, Sodium Chloride or none of both). Main study parameter is urinary renin levels. |
De studie stopt na 4 weken (waarin de patient Natriumbicarbonaat, Natriumchloride of geen van beide krijgt). Belangrijkste parameter is het urine-renine. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
not applicable |
niet van toepassing |
|
E.5.2 | Secondary end point(s) |
not applicable |
niet van toepassing |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
not applicable |
niet van toepassing |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
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 | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
tijds-controle |
time-control |
|
E.8.2.4 | Number of treatment arms in the trial | 3 |
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 | 4 |
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 | No |
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
|
the last visit of the last subject undergoing the trial |
laatste bezoek van laatste patient |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |