A Study to Evaluate Lumasiran in Adults With Recurrent Calcium Oxalate Kidney Stone Disease and Elevated Urinary Oxalate Levels

Alnylam Pharmaceuticals

Status and phase: Terminated; Phase 2

Conditions: Recurrent Calcium Oxalate Kidney Stone Disease; Elevated Urinary Oxalate Levels

Treatments: Drug: Placebo; Drug: Lumasiran

Study type: Interventional

Funder types: Industry

Identifiers

NCT05161936

ALN-GO1-008

Details and patient eligibility

About

The primary purpose of this study is to evaluate the effect of lumasiran on the percent change in urinary oxalate excretion in patients with recurrent calcium oxalate kidney stone disease.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Documented diagnosis of recurrent kidney stone disease based on ≥2 stone events with a minimum of 1 stone event within 5 years prior to screening
• Meets the 24 hour urine oxalate excretion requirements
• 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

Exclusion criteria

• Known history of secondary causes of elevated urinary oxalate and/or recurrent kidney stones
• Primary hyperoxaluria
• Estimated glomerular filtration rate (eGFR) of <30 mL/min/1.73m^2 at screening
• Received an investigational agent within the last 30 days or 5 half-lives, whichever is longer

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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2 participants in 3 patient groups, including a placebo group

Lumasiran Dose 1

Experimental group

Description:

Participants will be administered lumasiran by subcutaneous (SC) injection.

Treatment:

Drug: Lumasiran

Lumasiran Dose 2

Experimental group

Description:

Participants will be administered lumasiran by SC injection.

Treatment:

Drug: Lumasiran

Placebo

Placebo Comparator group

Description:

Participants will be administered placebo by SC injection.

Treatment:

Drug: Placebo