Recurrent calcium oxalate kidney stone disease MedDRA version: 20.0 Level: LLT Classification code 10023436 Term: Kidney stone System Organ Class: 100000004857
Conditions
Interventions
Product Name: lumasiran
Product Code: ALN-GO1
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Lumasiran sodium
CAS Number: 1834612-06-4
Current Sponsor code: ALN-G01
Other descriptive
Sponsors
Alnylam Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age 18 years or older (or age of legal consent, whichever is older). • Recurrent kidney stone disease, defined as =2 stone events within the 5 years prior to screening. For inclusion, a historical kidney stone event is defined as: 1. the visible passage of a kidney stone 2. a procedural intervention for removal of an asymptomatic or symptomatic stone 3. a new (=1 mm) or enlarged (by =2 mm) kidney stone on CT imaging • The 2 most recently analyzed kidney stones prior to randomization contained 50% or more of calcium oxalate; if only one stone analysis is available, then it must have contained 50% or more of calcium oxalate. • 24-hour urinary oxalate levels from 2 valid 24-hour urine collections obtained during screening are >ULN. • Willing to adhere to dietary recommendations appropriate for stone formers including limiting vitamin C supplementation to =65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: • Has any of the following laboratory parameter assessments at screening: a. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 × ULN b. Total bilirubin >1.5 × ULN. Patients with elevated total bilirubin that is secondary to documented Gilbert’s syndrome are eligible if the total bilirubin is 2.0 (patients on oral anticoagulant [eg, warfarin] with an INR <3.5 will be allowed) • Has an eGFR of <30 mL/min/1.73m2 at screening (calculation will be based on the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] creatinine formula; • Received an investigational agent within the last 30 days or 5 half-lives, whichever is longer, prior to the first dose of study drug, or are in follow-up of another clinical study prior to study enrollment • Patients with a known history of secondary causes of elevated urinary oxalate and/or recurrent kidney stones including: a. Primary hyperoxaluria b. Severe eating disorders (anorexia or bulimia) c. Chronic inflammatory bowel disease d. Intestinal surgery with malabsorption or chronic diarrhea e. Sarcoidosis f. Primary hyperparathyroidism g. Complete distal renal tubular acidosis • Has other medical conditions or comorbidities which, in the opinion of the Investigator, would interfere with study compliance or data interpretation. • History of multiple drug allergies or history of allergic reaction to an oligonucleotide or GalNAc. • History of intolerance to SC injection(s) • Is not willing to comply with the contraceptive requirements during the study period • Female patient is pregnant, planning a pregnancy, or breast-feeding • Unwilling or unable to limit alcohol consumption throughout the course of the study • History of alcohol abuse, within the last 12 months before screening, in the opinion of the Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of lumasiran on the percent change in urinary oxalate excretion;Secondary Objective: • To evaluate the percentage of patients who achieve a =20% reduction in 24-hour urinary oxalate with lumasiran • To evaluate the effect of lumasiran on urinary calcium oxalate supersaturation;Primary end point(s): Percent change in 24-hour urinary oxalate from baseline to Month 6 (average across Months 4 through 6);Timepoint(s) of evaluation of this end point: From baseline to Month 6 (average across Months 4 through 6) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Percentage of patients who achieve a =20% reduction in 24-hour urinary oxalate from baseline to Month 6 (average across Months 4 through 6) • Percent change in urinary calcium oxalate supersaturation from baseline to Month 6 (average across Months 4 through 6);Timepoint(s) of evaluation of this end point: From baseline to Month 6 (average across Months 4 through 6) | — |
Countries
Belgium, Italy, Spain, Switzerland, United Kingdom, United States
Contacts
Public ContactClinical Trials Information Line
Alnylam Pharmaceuticals, Inc.
Outcome results
None listed