Kortsigtede virkninger af en SGLT2-hæmmer på divalente ioner ved autosomal dominant polycystisk nyresygdom (SIDIA)
This study aims to better understand electrolyte handling in patients with autosomal dominant polycystic kidney disease treated with the SGLT2 inhibitor Empagliflozin.
Patients will be randomized into two groups and take Empagliflozin or a Placebo for 2 weeks with a wash-out period of 2 weeks. The primary outcome is tubular handling of the divalent ions calcium, phosphate and magnesium. Secondary outcomes include diuresis, safety and tolerability.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This investigator-initiated randomised, single-blind, placebo-controlled cross-over study aims to better understand tubular electrolyte handling of divalent ions in patients with autosomal dominant polycystic kidney disease treated with the SGLT2 inhibitor Empagliflozin.
After randomization, at week 0, participants collect 24-hour urine sample and a patient visit to assess vitals and blood tests takes place. After this visit, period 1 starts with a 2-week treatment of either Empagliflozin 10mg or Placebo.
At week 2, the second 24-hour-urine sample and 2. patient visit and blood test take place. After this visit, wash-out period for 2 weeks starts where no study drug will be administered At week 4, the period 2, the crossover-period starts for an additional 2 weeks. At week 6; a final and third 24-hour urine sample, clinical visit and blood test takes place.
At week 3 & 7, a phone consultation will assess safety.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
Canton of Zurich
-
Zurich, Canton of Zurich, Schweiz, 8091
- University Hospital Zurich, Division of Nephrology
-
-
Kanton Graubünden
-
Chur, Kanton Graubünden, Schweiz, 7000
- Cantonal Hospital Graubuenden
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- - Patients 18-75 years old with ADPKD, defined according to international diagnostic and classification criteria14, treated at Cantonal Hospital Graubünden (KSGR) and the University Hospital Zürich (USZ) independent of baseline treatment with the vasopressin receptor antagonist Tolvaptan
- Informed consent as documented by signature
Exclusion Criteria:
- - renal replacement therapy or kidney allograft recipient
- chronic kidney disease CKD KDIGO Stage G4 (eGFR under 30ml/min/1.73m2)
- patients younger 18 years of age
- Diabetes mellitus type 1
- recurrent urinary tract infections (UTI) defined as more than 3 infections requiring antibiotic treatment or over 1 requiring hospitalization/year.
- Patients with uncontrolled hypertension (defined as ambulatory systolic BP over 180mmHg), liver cirrhosis (Child Pugh B and C)
- Patients not able or not willing to stop the following medications during the study period of participation in the trial:
- Thiazide diuretics
- Carbonic anhydrase inhibitors
- Sodium bicarbonate
- 1, 25 (OH) vitamin D (calcitriol)
- Bisphosphonate, denosumab, teriparatide
- Pregnant or lactating women
- Known allergy to study drug
- Inability to understand and follow the protocol
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Intervention
Empagliflozin 10mg |
Empagliflozin 10mg |
|
Placebo komparator: Control
Placebo |
Placebo capsule |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
24-hour Urinary Phosphate
Tidsramme: End of each 14 day treatment period
|
Total phosphate excretion measured in a 24-hour urine collection at the end of each treatment period. |
End of each 14 day treatment period
|
|
24-hour Urinary Calcium Excretion
Tidsramme: End of each 14-day treatment period
|
Effect of empagliflozin compared with placebo on 24-hour urinary calcium excretion after each 14-day treatment period in a randomized crossover trial. |
End of each 14-day treatment period
|
|
24-hour Urinary Magnesium Excretion
Tidsramme: End of each 14-day treatment period
|
Effect of empagliflozin compared with placebo on 24-hour urinary magnesium excretion after each 14-day treatment period in a randomized crossover trial. |
End of each 14-day treatment period
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Serum Phosphate
Tidsramme: End of each 14-day treatment period
|
Effect of empagliflozin compared with placebo on serum phosphate after each 14-day treatment period. |
End of each 14-day treatment period
|
|
Serum Calcium
Tidsramme: End of each 14-day treatment period
|
Effect of empagliflozin compared with placebo on serum calcium after each 14-day treatment period. |
End of each 14-day treatment period
|
|
Serum Magnesium
Tidsramme: End of each 14-day treatment period
|
Effect of empagliflozin compared with placebo on serum magnesium after each 14-day treatment period. |
End of each 14-day treatment period
|
|
24-hour Urine Volume
Tidsramme: End of each 14-day treatment period
|
Total urine volume collected over 24 hours at the end of each treatment period. |
End of each 14-day treatment period
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Thomas Fehr, MD, Cantonal Hospital Graubuenden
- Ledende efterforsker: Patrick Hofmann, MD, Cantonal Hospital Graubuenden
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Ciliopatier
- Urogenitale sygdomme
- Mandlige urogenitale sygdomme
- Nyresygdomme
- Urologiske sygdomme
- Urogenitale sygdomme hos kvinder
- Kvinders urogenitale sygdomme og graviditetskomplikationer
- Genetiske sygdomme, medfødte
- Medfødte abnormiteter
- Abnormiteter, multiple
- Nyresygdomme, Cystisk
- Polycystiske nyresygdomme
- Medfødte, arvelige og neonatale sygdomme og abnormiteter
- Polycystisk nyre, autosomal dominant
- Empagliflozin
Andre undersøgelses-id-numre
- 2024-00070
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
The local ethics committee approval does not include individual participant data sharing.
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