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Clinical Trial Details

Trial ID: L0391
Source ID: NCT05870007
Associated Drug: Atorvastatin 20 Mg Oral Tablet
Title: Atorvastatin and Alkali Therapy in Patients With Autosomal Dominant Polycystic Kidney Disease
Acronym:
Status: ENROLLING_BY_INVITATION
Study Results: NO
Results:
Conditions: Autosomal Dominant Polycystic Kidney Disease|Chronic Kidney Diseases
Interventions: DRUG: Atorvastatin 20 Mg Oral Tablet|DRUG: Sodium Bicarbonate 600 Mg Oral Tablet
Outcome Measures: Primary: Changes in kidney function in patients enrolled in different arms of the study, The investigators will estimate the effect of Atorvastatin and NaHCO3 on kidney function in patients with ADPKD compared to Atorvastatin alone or Standard therapy: serum creatinine-derived estimated glomerular filtration rate (eGFR) calculated by CKD-EPI equation, to evaluate kidney function., 12 months|Changes in kidney function in patients enrolled in different arms of the study, The investigators will estimate the effect of Atorvastatin and NaHCO3 on kidney function in patients with ADPKD compared to Atorvastatin alone or Standard therapy: serum blood urea nitrogen (BUN), to evaluate kidney function., 12 months|Changes in kidney function in patients enrolled in different arms of the study, The investigators will estimate the effect of Atorvastatin and NaHCO3 on kidney function in patients with ADPKD compared to Atorvastatin alone or Standard therapy: serum sodium level (Na), to evaluate kidney function., 12 months|Changes in kidney function in patients enrolled in different arms of the study, The investigators will estimate the effect of Atorvastatin and NaHCO3 on kidney function in patients with ADPKD compared to Atorvastatin alone or Standard therapy: serum potassium level (K), to evaluate kidney function., 12 months|Changes in liver function in patients enrolled in different arms of the study, The investigators will test liver function test panels in patients with ADPKD compared to Atorvastatin alone or Standard therapy. The liver function panel should be within normal limits for enrollment and continuation in the study. Liver function test with ALT will be evaluated at the end of the trial., 12 months|Changes in liver function in patients enrolled in different arms of the study, The investigators will test liver function test panels in patients with ADPKD compared to Atorvastatin alone or Standard therapy. The liver function panel should be within normal limits for enrollment and continuation in the study. Liver function test with AST will be evaluated at the end of the trial., 12 months|Changes in liver function in patients enrolled in different arms of the study, The investigators will test liver function test panels in patients with ADPKD compared to Atorvastatin alone or Standard therapy. The liver function panel should be within normal limits for enrollment and continuation in the study. Liver function test with total bilirubin will be evaluated at the end of the trial., 12 months|Changes in liver function in patients enrolled in different arms of the study, The investigators will test liver function test panels in patients with ADPKD compared to Atorvastatin alone or Standard therapy. The liver function panel should be within normal limits for enrollment and continuation in the study. Liver function test with increase in prothrombin time will be evaluated at the end of the trial., 12 months|Changes in muscle injury marker function in patients enrolled in different arms of the study, The investigators will estimate the effect of Atorvastatin and NaHCO3 on creatine phospho kinase (CPK) in patients with ADPKD compared to Atorvastatin alone or Standard therapy., 12 months|Changes in muscle tenderness in patients enrolled in the study, The investigators will estimate the effect of Atorvastatin and NaHCO3 on muscle tenderness in patients with ADPKD compared to Atorvastatin alone or Standard therapy. The physical exam will evaluate tenderness to palpation in major muscle groups such as leg, arm and back muscles. It will be graded as presence or absence. The patients will only be enrolled if there is absence of tenderness in muscles upon palpation on physical exam. If there is tenderness on exam or the patient reports tenderness that is then confirmed by exam the patient will be removed from the study., 12 months|Changes in blood pressure in patients enrolled in different arms of the study, The investigators will estimate the effect of Atorvastatin and NaHCO3 on blood pressure (systolic and diastolic) in patients with ADPKD compared to Atorvastatin alone or Standard therapy, 12 months | Secondary: Urinary alkalinization changes, These parameters will be ascertained by measurements of urinary pH., 12 months|Inflammatory markers in blood and urine, The investigators will assess inflammatory markers (interleukins, prostaglandins and other cytokines) in leukocytes, plasma, and urine in the different study groups. The biomarkers that will be measured are HETE / HODE species phospho-AMPK Inflammatory and metabolic biomarkers: NGAL, KIM1 in blood and urine., 12 months|AMPK pathway activation, The investigators will determine whether and to what extent the AMPK pathway is activated in leukocytes and urine derived from patients in the study groups at the different study visits. Concentration of AMPK pathway-related metabolites in serum and urine would be measured (Creatinine, Osmolality, Lactate, Pyruvate, Succinate, Total Protein, PKM2, LDHA, PDK1)., 12 months
Sponsor/Collaborators: Sponsor: Taipei Medical University Shuang Ho Hospital | Collaborators: University of Southern California
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 30
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-05
Completion Date: 2026-12
Results First Posted:
Last Update Posted: 2023-05-23
Locations: Shuang Ho Hospital, New Taipei City, 235, Taiwan|Taipei Medical University Hospital, Taipei, Taiwan|Wan Fang Hospital, Taipei, Taiwan
URL: https://clinicaltrials.gov/show/NCT05870007