ZIRCUSEffets du Sodium Zirconium Cyclosilicate (Lokelma) sur l'albuminurie chez les patients atteints de diabète de type 2 avec hyperkaliémie
Cette étude vise à évaluer l'effet du Sodium Zirconium Cyclosilicate (Lokelma) sur l'albuminurie, mesurée par le rapport albumine créatinine urinaire, chez les patients atteints de diabète de type 2 qui présentent également une hyperkaliémie.
LOKELMA 5 GM Powder for Oral Suspension
+ Placebos
Hyperkaliémie+1
+ Maladies métaboliques
+ Maladies nutritionnelles et métaboliques
Étude thérapeutique
Résumé
Date de début de l'étude : 1 octobre 2019
Date à laquelle le premier participant a commencé l'étude.This study focuses on patients with type 2 diabetes who also have hyperkalemia, a condition where potassium levels in the blood are too high. High potassium levels can be a side effect of certain treatments for diabetes, and can lead to changes in these treatments, which may not be beneficial in the long term. The study aims to investigate the effects of a drug called Sodium Zirconium Cyclosilicate, also known as Lokelma, on managing hyperkalemia and improving the effectiveness of diabetes treatments. The study is important as it could potentially improve care for patients with type 2 diabetes and hyperkalemia, helping to address current challenges in their treatment. The study is designed as a randomized, double-blind, placebo-controlled trial, meaning some participants will receive Lokelma, while others will receive a placebo that looks the same but contains no active drug. The study takes place across several centers in Sweden and Denmark, and lasts for 12 weeks. The main goal is to measure changes in the urinary albumin creatinine ratio (UACR), a key indicator of kidney function, from the start to the end of the treatment period. This will help determine the effectiveness of Lokelma in managing hyperkalemia and improving kidney health in patients with type 2 diabetes.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.20 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 18 à 85 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Inclusion Criteria: 1. Provision of informed consent prior to any study specific procedures 2. Female and/or male patients with type 2 diabetes aged 18-85 years 3. Persistent macroalbuminuria (UACR ≥ 200 mg/g in at least two out of the three latest UACR measurements in subject history). 4. Chronic (at least 1 month) stable RAAS blocking treatment, i.e maximum tolerated (individually defined by investigator) dose of an ACE inhibitor or ARB at time of inclusion. 5. Documented hyperkalemia (plasma potassium ≥ 5.0 mmol/l) at least once in the 90 days prior to inclusion in the study. 6. Negative pregnancy test (urine or serum) for female subjects of childbearing potential. 7. Female subjects must be 1 year post-menopausal, surgically sterile, or using an acceptable method of contraception (an acceptable method of contraception is defined as a barrier method in conjunction with a spermicide) for the duration of the study (from the time they sign consent) and for 3 months after the last dose of Lokelma/matching placebo to prevent pregnancy. In addition, oral contraceptives, approved contraceptive implant, long-term injectable contraception, intrauterine device, or tubal ligation are allowed. Oral contraception alone is not acceptable; additional barrier methods in conjunction with spermicide must be used. Exclusion Criteria: 1. Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site) 2. Previous enrolment in the present study 3. Use of potassium-lowering agent (loop-diuretics not included) 4. Participation in another clinical study with an investigational product during the last 3 months prior to inclusion. 5. Plasma potassium \< 3.5 mmol/l within the previous six months before inclusion. 6. Known hypersensitivity to Lokelma 7. Known history of drug or alcohol abuse within 1 year of screening 8. Estimated glomerular filtration rate (eGFR) \<15 ml/min/1.73 m2 (calculated by CKD-EPI formula). 9. History of long QT syndrome. 10. For women only - currently pregnant (confirmed with positive pregnancy test) or breast feeding.
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.2 groupes d'intervention sont désignés dans cette étude
50% de chances d'être dans le groupe placebo en aveugle
Groupes de traitement
Groupe I
Comparateur actifGroupe II
PlaceboObjectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
Steno Diabetes Center Copenhagen
Gentofte Municipality, DenmarkOuvrir Steno Diabetes Center Copenhagen dans Google Maps