A Study to Evaluate Lumasiran in Adults With Recurrent Calcium Oxalate Kidney Stone Disease and Elevated Urinary Oxalate Levels
NCT05161936 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2
Last updated 2024-05-22
Summary
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.
Conditions
- Recurrent Calcium Oxalate Kidney Stone Disease
- Elevated Urinary Oxalate Levels
Interventions
- DRUG
-
Lumasiran
Lumasiran will be administered by SC injection.
- DRUG
-
Placebo will be administered by SC injection.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Medical Director · Alnylam Pharmaceuticals
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-01-27
- Primary Completion
- 2022-11-01
- Completion
- 2022-11-01
- FDA Drug
- Yes
Countries
- United States
- Belgium
- Italy
- Spain
- Switzerland
- United Kingdom
Study Locations
More Related Trials
-
Evaluate the Effect of ALLN-177 in Reducing Urinary Oxalate in Patients With Secondary Hyperoxaluria and Kidney Stones Over 28 Days
NCT02547805 ·Status: COMPLETED ·Phase: PHASE2
-
Lumasiran in Hyperoxalaemic Patients on Haemodialysis
NCT06225544 ·Status: RECRUITING ·Phase: PHASE2
-
Retrospective and Prospective Follow-up of Patients With Primary Hyperoxaluria Type 1 Treated With Lumasiran in France.
NCT06225882 ·Status: RECRUITING
-
Efficacy and Safety of Lanthanum Carbonate and Sevelamer Hydrochloride in Patients Receiving Haemodialysis for End Stage Renal Disease
NCT00151918 ·Status: COMPLETED ·Phase: PHASE3
-
Pharmacodynamic Study of Two Lanthanum Carbonate Formulations in Healthy Adults
NCT00880750 ·Status: COMPLETED ·Phase: PHASE1
-
A Randomised, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sevelamer Carbonate Tablets Dosed Three Times a Day in Hyperphosphataemic Chronic Kidney Disease Patients Not on Dialysis
NCT00833768 ·Status: TERMINATED ·Phase: PHASE3
-
Safety of Lixivaptan in Subjects Previously Treated With Tolvaptan for Autosomal Dominant Polycystic Kidney Disease
NCT04152837 ·Status: TERMINATED ·Phase: PHASE3
-
A Study of Lanabecestat in Participants With Severe Kidney Impairment Compared to Healthy Participants
NCT03545087 ·Status: WITHDRAWN ·Phase: PHASE1
-
Lanthanum Carbonate (Fosrenol®) to Reduce Oxalate Excretion in Patients With Secondary Hyperoxaluria and Nephrolithiasis
NCT03346369 ·Status: UNKNOWN ·Phase: PHASE3
-
Efficacy, Safety and Tolerability of Balcinrenone/Dapagliflozin Compared to Dapagliflozin in Adults With Chronic Kidney Disease
NCT06350123 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Evaluate Safety, Tolerability, PK and PD of DCR-PHXC in PH Type 3 Patients
NCT04555486 ·Status: COMPLETED ·Phase: PHASE1
-
Comparing Absorption of Dietary Phosphorus When Administering FOSRENOL® or RENVELA® in Healthy Adult Volunteers
NCT00875017 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy, Safety and Tolerability of Everolimus in Preventing End-stage Renal Disease in Patients With Autosomal Dominant Polycystic Kidney Disease
NCT00414440 ·Status: COMPLETED ·Phase: PHASE4
-
A Phase III, Multicentre, Double-Blind, Placebo-Controlled Withdrawal Study in Patients With Hyperphosphatemia
NCT00416520 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of Lanthanum Carbonate in Reducing Serum Phosphorus Levels in Subjects With Stage 3 and 4 Chronic Kidney Disease
NCT00234702 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Tolerability of FB-001 in Healthy Adult Volunteers and Adult Subjects With Enteric Hyperoxaluria
NCT05650112 ·Status: UNKNOWN ·Phase: PHASE1
-
Effect of Phosphate Binders on Markers of Vascular Health in Chronic Kidney Disease Stages 3 and 4
NCT01277497 ·Status: TERMINATED ·Phase: PHASE4
-
A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) (2) [Extension of Study 156-05-002]
NCT01022424 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Tolerability of Treatment With Lanthanum Carbonate in Patients With End Stage Renal Disease Receiving Dialysis
NCT00151931 ·Status: COMPLETED ·Phase: PHASE3
-
Safety & Efficacy of DCR-PHXC in Patients With PH1 and ESRD
NCT04580420 ·Status: RECRUITING ·Phase: PHASE2
-
Efficacy and Safety of Tolvaptan in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease
NCT02160145 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Investigate the Safety of LT5001 Drug Product for Uremic Pruritus in Hemodialysis Patients
NCT04393675 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
A Study to Assess the Tolerability of Oxylanthanum Carbonate in Patients With Chronic Kidney Disease on Dialysis
NCT06218290 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Assess the Safety and the Phosphate Binding Capacity of Renazorb
NCT01560884 ·Status: COMPLETED ·Phase: PHASE1
-
8-Week Study of Tolvaptan Dose Forms in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
NCT01451827 ·Status: COMPLETED ·Phase: PHASE2