Phase 2 N=22 Hydroxyproline Influence on Oxalate Metabolism
Hyperoxaluria
Primary: Mean Percent Conversion of Hydroxyproline (Hyp) to Urinary Oxalate (UOx) — 12.8; 32.9; 14.8 percent converted
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
N/A N=22 A Pilot Study of Oxalate Absorption in Secondary Hyperoxaluria
Secondary Hyperoxaluria · Nephrolithiasis · Hyperoxaluria
Primary: Percent of Oxalate Absorption Normalized by Baseline Urinary Oxalate Excretion Over a 24 Hour Test Period — 2.84 percentage of oxalate absorption
Phase 2 N=10 Oxazyme in Patients With Hyperoxaluria
Hyperoxaluria
Primary: Urinary Oxalate Creatinine Ratio — 68.6; 38.7; 49.6; 34.7 mg/g — p=0.027
Phase 2 N=12 Study to Evaluate the Efficacy and Safety of Oxabact (OC5) in Primary Hyperoxaluria Patients Who Are on Dialysis
Primary Hyperoxaluria
Primary: Change in Pre Dialysis Plasma Oxalate (Total Plasma Oxalate) Level During Treatment With OC5 Compared With Baseline. — 147.57; 11.34; 7.46; -5.68 μmol/L
Phase 3 N=25 A Study to Evaluate the Efficacy and Safety of Oxabact in Patients With Primary Hyperoxaluria
Primary Hyperoxaluria
Primary: Change From Baseline in Plasma Oxalate Concentration After 52 Weeks of Treatment — 14.8; 14.4; -0.71; 2.35 micromole/liter
N/A N=58 Obesity and Endogenous Oxalate Synthesis
Obesity
Primary: Urinary Oxalate Excretion — 24 mg/day
Phase 2 N=16 Evaluating ALLN-177 for Reducing Urinary Oxalate Excretion in Calcium Oxalate Kidney Stone Formers With Hyperoxaluria
Hyperoxaluria · Nephrolithiasis
Primary: Change From Baseline Period to Treatment Period 24-hour Urinary Oxalate Excretion — -13.92 mg/day
Phase 2 N=35 A Study to Evaluate DCR-PHXC in Children and Adults With Primary Hyperoxaluria Type 1 and Primary Hyperoxaluria Type 2
Primary Hyperoxaluria Type 1 (PH1) · Primary Hyperoxaluria Type 2 (PH2) · Kidney Diseases
Primary: AUC From Day 90 To Day 180, Based on Percent Change From Baseline in 24-Hour Uox — 3507.4; -1664.4 Percent change in 24-hour Uox AUC — p=<0.0001
Phase 2 N=13 Efficacy of Betaine for Reduction of Urine Oxalate in Patients With Type 1 Primary Hyperoxaluria
Hyperoxaluria
Primary: Urinary Oxalate Excretion — 1.43; 1.04 umol/mg — p=0.007
N/A N=23 Assessment of Endogenous Oxalate Synthesis
Healthy · Kidney Stone · Obesity
Primary: Endogenous Oxalate Synthesis Rate — 17 mg/day
Phase 2 N=40 Use of Oral Probiotics to Reduce Urinary Oxalate Excretion
Nephrolithiasis · Hyperoxaluria · Crohn's Disease
Primary: Change in 24-hour Urinary Supersaturation for Calcium Oxalate — 1.40; 1.36; 1.42 KJoules/mol — p=0.3
Phase 2 N=20 An Extension Study of an Investigational Drug, Lumasiran (ALN-GO1), in Participants With Primary Hyperoxaluria Type 1
PH1 · Primary Hyperoxaluria · RNAi Therapeutic
Primary: Number of Participants With at Least One Adverse Event (AE) — 13; 7 Participants
N/A N=20 Suspected Deficient Activation of Vitamin D in Patients With Secondary Hyperparathyroidism
Secondary Hyperparathyroidism
Primary: The Level of Activated Vitamin D (1,25-dihydroxyvitamin D) After Parathyroid Hormone Infusion at Baseline, 4 and 8 Hours — 40.6; 46.2; 39.8; 58.8 pg/ml — p=0.1
Phase 3 N=39 A Study to Evaluate Lumasiran in Children and Adults With Primary Hyperoxaluria Type 1
Primary Hyperoxaluria Type 1 (PH1)
Primary: Percent Change in 24-hour Urinary Oxalate Excretion Corrected for Body Surface Area (BSA) From Baseline to Month 6 — -11.8; -65.4 percent change — p=<0.0001
Phase 2 N=99 Febuxostat Versus Allopurinol or Placebo in Patients With Hyperuricosuria and Calcium Oxalate Stones
Hyperuricosuria · Kidney Stones
Primary: Percent Change From Baseline to Month 6 in 24-hour Urine Uric Acid (uUA) Excretion — -58.6; -36.4; -12.7 percent change — p=<0.001
Phase 3 N=21 A Study to Evaluate Lumasiran in Patients With Advanced Primary Hyperoxaluria Type 1
Primary Hyperoxaluria Type 1 · Primary Hyperoxaluria
Primary: Cohort A: Percent Change in Plasma Oxalate From Baseline to Month 6 — -33.33 percent change
Phase 2 N=10 The Effect of Sodium-glucose Cotransporter (SGLT) 2 Inhibitors on Cystine Stone Formation: A Preliminary Study
Cystinuria
Primary: 24hr Urine Measurements of the Effect of SGLT-2 Inhibitor Therapy on Cystine Production in Urine in Patients With Cystinuria — 999.3 24hr urine cystine concentration…
Early Phase 1 N=16 Calcitriol Monotherapy for X-Linked Hypophosphatemia
X-linked Hypophosphatemia · Hypophosphatemic Rickets · Hypophosphatemic Rickets, X-Linked Dominant
Primary: Change in Serum Phosphate in Adults and Children With XLH Between Baseline and 12 Months — 2.6; 2.1 mg/dl — p=0.318
N/A N=26 Oxalobacter Formigenes Colonization and Urinary Oxalate Excretion
Calcium Oxalate Urolithiasis
Primary: Percent Decrease in Urinary Oxalate Excretion After Colonization With O.Formigenes — 14 Percentage decrease in urinary oxalate
Phase 4 N=9 Effect of Allopurinol and Febuxostat on Urinary 2,8-Dihydroxyadenine Excretion
Adenine Phosphoribosyltransferase Deficiency
Primary: Urinary 2,8-dihydroxyadenine Excretion — 116; 45; 13 mg/24-h — p=<.05
Phase 3 N=18 A Study of Lumasiran in Infants and Young Children With Primary Hyperoxaluria Type 1
Primary Hyperoxaluria · Primary Hyperoxaluria Type 1 (PH1)
Primary: Percentage Change in Spot Urinary Oxalate:Creatinine Ratio From Baseline to Month 6 — -71.97 percent change
Phase 3 N=30 Sevelamer and Secondary Hyperparathyroidism in Chronic Kidney Disease
Hyperparathyroidism · Chronic Kidney Disease
Primary: Fractional Change in [PTH] in CKD After a 4-week Course of Sevelamer Carbonate — -11.7; 16.4 percentage of baseline [PTH]
Phase 2 N=32 Study of Lumasiran in Healthy Adults and Patients With Primary Hyperoxaluria Type 1
Primary Hyperoxaluria Type 1 (PH1)
Primary: Number of Participants With Adverse Events (AEs) — 5; 6; 2; 6 Participants
N/A N=10 Role of Extrarenal 1-Alpha-Hydroxylase in Patients With End Stage Renal Disease
End-Stage Renal Disease
Primary: Change in Monocyte VDR Expression With Vitamin D Therapy — 1899 units on a scale
Phase 2 N=54 Study for Secondary Hyperparathyroidism in Chronic Renal Insufficiency Patients
Secondary Hyperparathyroidism · Chronic Renal Insufficiency
Primary: Reduction in Mean iPTH of ≥ 30% During the Efficacy Assessment Phase — 15; 5 Participants — p=0.006
Phase 3 N=33 Effectiveness of Paricalcitol in Reducing Parathyroid Hormone (PTH) Levels in X-linked Hypophosphatemic Rickets
Hypophosphatemia, Familial · Hyperparathyroidism
Primary: Area Under the Curve for Parathyroid Hormone (PTHauc) Measurement — 1223; 1449; 987; 1616 nlEq*26hr/ml — p=0.007
Phase 2 N=30 Role Of Phosphorus And FGF 23 In Patients With Dent Disease
Dent Disease
Primary: Change in Urine Total Protein — 1681; 59 mg/day
Phase 3 N=49 Trial Of Paricalcitol and Cholecalciferol(Vitamin D3) in the Treatment Of Secondary Hyperparathyroidism in Patients After ROUX-EN-Y Gastric Bypass Surgery
Gastric Bypass · Parathyroid Hormone
Primary: The Primary Outcome Measure With iPTH — 72; 87; 82 pg/mL
Phase 4 N=110 Paricalcitol Versus Calcitriol for Efficacy and Safety in Stage 3/4 Chronic Kidney Disease (CKD) With Secondary Hyperparathyroidism (SHPT)
Secondary Hyperparathyroidism · Chronic Kidney Disease
Primary: Confirmed Hypercalcemia — 3; 1 participants — p=0.36
Phase 2 N=13 Treatment for Calcium Phosphate Kidney Stone Disease
Calcium Phosphate Kidney Stones
Primary: Urinary Calcium Phosphate Saturation — 2.38; 1.97; 2.19 no units