Last updated: May 19, 2023
Sponsor: Taipei Medical University Shuang Ho Hospital
Overall Status: Active - Enrolling
Phase
2
Condition
Kidney Failure
Treatment
Sodium Bicarbonate 600 Mg Oral Tablet
Atorvastatin 20 Mg Oral Tablet
Clinical Study ID
NCT05870007
TMU-JIRB N202208049
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patient voluntarily gives informed consent to participate in the study and signedstudy's IC and HIPAA.
- Patient is age 18 or older at the time of consent.
- If applicable, female of reproductive potential (Females who are successfullysterilized (surgical sterilization methods include hysterectomy, bilateral tuballigation, or bilateral oophorectomy) or are postmenopausal (defined as amenorrhea forat least 12 consecutive months) are not considered to be of reproductive potential)must be non-pregnant (as confirmed by a urine pregnancy test at screening) andnon-lactating, and agree:
- Either abstain from intercourse (when it is in line with their preferred andusual lifestyle), or
- Use 2 medically acceptable, highly-effective forms of contraception for theduration of study, and at least 30 days after discontinuing study drug (highly-effective forms of contraception can include approved hormonalcontraceptives (oral, injectable, and implantable), and barrier methods (such asa condom or diaphragm) when used with a spermicide.))
- Patients has ADPKD diagnosed by unified criteria using a combination of ultrasoundresults, genotyping and MRI as needed (1, 2). Kidney ultrasound is usually used forscreening because it is safe, effective, and inexpensive. Diagnostic criteria arebased upon whether the genotype is known. Disease severity varies between thedifferent genotypes. The great majority of patients at risk for ADPKD are fromfamilies with an unknown genotype. This diagnosis will take place prior to recruitment / inclusion into the study. The following ultrasonographic criteria for the diagnosis of ADPKD are for at-riskpatients from families of where the genotype is not known:
- If the patient is between 18 and 39 years of age, at least three unilateral orbilateral kidney cysts. The specificity and positive predictive value at thisage-range is 100 percent. (sensitivity of 82 and 96 percent for individualsbetween 15 and 29 years and between 30 to 39 years of age, respectively).
- If the patient is 40 to 59 years of age, at least two cysts in each kidney (sensitivity, specificity, and positive predictive value of 90, 100, and 100percent, respectively).
- Among individuals 60 years or older, at least four cysts in each kidney. (100percent sensitivity and specificity).
- The above patients with estimated GFR ≥30 ml/min i.e. with stage 1-3b CKD
- Plasma bicarbonate ≤ 25 mMol/L
- Metabolic acidosis
- The patient agrees to immediately inform Investigator and research coordinator of anychanges or planned changes in concomitant medication
Exclusion
Exclusion Criteria:
- Patients with known allergy or sensitive to Atorvastatin or NaHCO3
- Acute coronary disease, liver disease, muscle disease, or a history of pulmonary edema
- Creatine Phospho Kinase (CPK) > 2ULN (2.5 ULN in African Americans). Elevated creatinephosphokinase could be a marker of rhabdomyolysis, which is a potential side effect ofpravastatin. In general, patients with African American ancestry can have highernormal level of CPK
- Patients with systemic disease that impacting kidney per Investigator's decision
- Patients with known unstable cerebral aneurysm per Investigator's decision
- Pregnancy or lactation, or patients who refuse to use recommended contraceptionmethods
- Proteinuria > 1000 mg/day
- History of non-compliance of medication per Investigator's decision
- Patients with uncontrolled hypertension, edema, or development of severe MA as perInvestigator's decision
- History of cancer
- History of liver disease: hepatic failure/shock, cirrhosis
- Current or planned use of any of prohibited concomitant medication
- Patients with history of nephrolithiasis Following medications prohibited at the time of enrollment and during the study and if thepatient is started on these medications then the patient will be excluded from the study: rapamycin or its analogues tolvaptan spironolactone cimetidine and ketoconazoleerythromycin cyclosporine gemfibrozil colchicine niacin (>1 g/day) other lipid loweringmedications in the class of statins
Study Design
Total Participants: 30
Treatment Group(s): 2
Primary Treatment: Sodium Bicarbonate 600 Mg Oral Tablet
Phase: 2
Study Start date:
May 01, 2023
Estimated Completion Date:
December 31, 2026
Connect with a study center
Shuang Ho Hospital
New Taipei City, 235
TaiwanSite Not Available
Taipei Medical University Hospital
Taipei,
TaiwanSite Not Available
Wan Fang Hospital
Taipei,
TaiwanSite Not Available

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