Ignite Creation Date:
2024-05-06 @ 7:03 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05870007
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-05-23
First Post:
2023-04-12
Brief Title:
Atorvastatin and Alkali Therapy in Patients With Autosomal Dominant Polycystic Kidney Disease
Sponsor:
Taipei Medical University Shuang Ho Hospital
Organization:
Taipei Medical University Shuang Ho Hospital
Study Overview
Official Title:
Atorvastatin and Alkali Therapy in Patients With Autosomal Dominant Polycystic Kidney Disease A Pilot Trial for Safety and Feasibility
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Polycystic Kidney Disease PKD is the most common genetic disease leading to End Stage Kidney Disease ESKD affecting between 1 in 500-1000 individuals from every ethnic group The autosomal dominant ADPKD form arises from a two-hit downregulation of proteins encoded by either PKD1 or PKD2 Although many potential therapies have been studied to slow progression of ADPKD none to date have been proven to be both safe and effective in slowing disease progression Cholesterol-lowering agents called statins have shown promise in the treatment of younger ADPKD patients reducing inflammation and progression as assessed by kidney growth but their utility appears to be limited in older populations and those with more advanced chronic kidney disease CKD Recent evidence suggests that acidosis as often seen in patients with worsening CKD and which may enhance CKD progression limits the effectiveness of statins and enhances their potential toxicity The investigators thus hypothesize that correction of acidosis along with statin treatment will be a safe and effective therapeutic regimen to slow CKD progression in the adult ADPKD population and improve overall quality of life in these patients To test this hypothesis the investigators will conduct a pilot open-label randomized clinical trial in ADPKD patients with estimated GFR 45 min Stage 1-3a CKD comparing three treatment groups control atorvastatin 20 mg po qd and atorvastatin plus sodium bicarbonate tablets upto 1800mg po total daily dose over one year At the beginning of the study the investigators will determine the genotype of the trial participants During the study period through study visits along with serial blood draws and urinary measurements the investigators will evaluate safety and tolerability of these treatment regimens follow renal function and investigate the role of these treatments on acidosis inflammatory and metabolic biomarkers in patients enrolled at an outpatient facility Serial follow-up imaging study will also be done in selected patients This study will establish the framework for larger clinical trials in ADPKD Moreover if the results of this study suggest safetytolerability or potential benefits of statins and alkali therapy in this ADPKD population the investigators will seek extramural funding for a larger clinical trial to test this therapeutic strategy in ADPKD
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None