N/A N=23 High Water Intake to Slow Progression of Polycystic Kidney Disease
Kidney, Polycystic, Autosomal Dominant
Primary: Change in Urine cAMP Concentration and Urine Osmolality (UOsm) — -2.6; -2.0 fold change in cAMP/UOsm (umol/UOsm)
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 3 N=34 Diet as a Potential Treatment for Autosomal Dominant Polycystic Kidney Disease
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Primary: Change in Mean Serum Copeptin From Baseline (a Reflection of Endogenous Vasopressin Production) at Week 2 — -0.86; 0.39 pmole/L — p=<0.01
Phase 2 N=169 Bosutinib For Autosomal Dominant Polycystic Kidney Disease
Polycystic Kidney, Autosomal Dominant
Primary: Change From Baseline (CFB) in Total Kidney Volume (TKV) at Month 25 — 1686.38; 1418.96; 1487.48; 1670.33 centimeter cube (cm^3) — p=<0.0001
Phase 2 N=97 Metformin as a Novel Therapy for Autosomal Dominant Polycystic Kidney Disease
Polycystic Kidney, Autosomal Dominant
Primary: Change in the Gastrointestinal Symptoms Rating Scale (GSRS) to 24 Months — -0.04; -0.11 score on a scale — p=0.50
Phase 2 N=18 Use of Low Dose Pioglitazone to Treat Autosomal Dominant Polycystic Kidney Disease
Polycystic Kidney Disease
Primary: Safety: Total Body Water — 45.78; 44.17 Ohms — p=0.024
Phase 4 N=431 Efficacy, Safety and Tolerability of Everolimus in Preventing End-stage Renal Disease in Patients With Autosomal Dominant Polycystic Kidney Disease
Autosomal Dominant Polycystic Kidney Disease
Primary: Primary Efficacy Analysis of Total Kidney Volume (mITT Set, Multiple Imputation) — 230.1; 300.8 mL
Phase 3 N=61 Mineralocorticoid Antagonism and Endothelial Dysfunction in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
ADPKD
Primary: Change From Baseline in Flow Mediated Dilation at 6 Months. — -0.2; -0.4 Percent change.
Phase 3 N=1,519 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
Chronic Kidney Disease · Autosomal Dominant Polycystic Kidney Disease
Primary: The Mean Annualized Change in eGFR From Pretreatment Baseline to Post-treatment Follow-up. — -2.339; -3.610 mL/min/1.73 m^2/year — p=<0.0001
Phase 2 N=31 The ELiSA Study - Evaluation of Lixivaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease
Autosomal Dominant Polycystic Kidney Disease
Primary: Maximum Observed Plasma Concentration (Cmax) of Lixivaptan in ADPKD Patients — 656.8; 190.9; 681.3; 156.9 ng/mL
Phase 3 N=558 HALT Progression of Polycystic Kidney Disease Study A
Kidney, Polycystic
Primary: Study A: Percent Annual Change in Total Kidney Volume — 6.0; 6.2; 5.6; 6.6 percentage of Total Kidney Volume — p=0.52
N/A N=60 Effect of Beetroot Juice on Reducing Hypertension in Autosomal Dominant Polycystic Kidney Disease
Autosomal Dominant Polycystic Kidney · Hypertension · Endothelial Dysfunction
Primary: Change in Clinic Systolic and Diastolic Blood Pressure From Baseline to 4 Weeks (End of Study) — -5.36; -7.65; -3.55; -2.73 mmHg
Phase 3 N=110 Effect of Statin Therapy on Disease Progression in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Polycystic Kidney, Autosomal Dominant
Primary: Percent of Participants Demonstrating 20% or More Increase in Total Kidney Volume — 69; 88 percentage of participants — p=0.03
N/A N=28 Daily Caloric Restriction and Intermittent Fasting in Overweight and Obese Adults With Autosomal Dominant Polycystic Kidney Disease
Polycystic Kidney, Autosomal Dominant
Primary: Feasibility to Enroll and Retain Participants — 122 Participants
Phase 2 N=29 Short-term Renal Hemodynamic Effects of Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Autosomal Dominant Polycystic Kidney Disease
Primary: Mean Change From Baseline in Measured Glomerular Filtration Rate (mGFR) After 3 Weeks of Tolvaptan Treatment and at 3 Weeks Post Treatment. — -8.0; -6.2; -0.7; 0.1…
Phase 2 N=37 A Safety, Pharmacokinetic & Dose-Escalation Study of KD019 in Subjects With Autosomal Dominant Polycystic Kidney Disease
Polycystic Kidney, Autosomal Dominant
Primary: Phase 1b: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAE) — 24; 8; 5; 1 Participants
Phase 3 N=1,445 Tolvaptan Phase 3 Efficacy and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Polycystic Kidney Disease, Autosomal Dominant
Primary: Percentage Change Per Year in Total Kidney Volume From Baseline to Month 36 — 2.777; 5.608 Percentage change per year — p=<0.0001
Phase 3 N=13 A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) (2) [Extension of Study 156-05-002]
Autosomal Dominant Polycystic Kidney Disease
Primary: Total Kidney Volume — 1428; 1675; 1728; 1775 mL
Phase 3 N=486 HALT Progression of Polycystic Kidney Disease Study B
Kidney, Polycystic
Primary: Number of Participants With 50% Reduction of Baseline eGFR, End Stage Renal Disease (ESRD, Initiation of Dialysis or Preemptive Transplant), or Death. — 116; 115…
Phase 2 N=17 A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Study 156-04-001]
Autosomal Dominant Polycystic Kidney Disease
Primary: Total Kidney Volume — 1500.5; 1573.1; 1567.9; 1729.4 mL
Phase 2 N=46 Tolvaptan Open-label Pilot Efficacy, Tolerability, and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Polycystic Kidney, Autosomal Dominant
Primary: Safety Assessments Based on Vital Signs, Electrocardiogram (ECG's), Clinical Laboratory Tests, Physical Examinations Are Reported as Adverse Events (AEs) Upon Study…
Phase 2 N=30 Pilot Study of Rapamycin as Treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Polycystic Kidney Diseases
Primary: Change in GFR From Baseline to 12 Months — 72.8; 70.3; 73.1; 74.4 ml/min/1.73m^2 — p=<0.01
Phase 3 N=91 Safety, Pharmacokinetics, Tolerability and Efficacy of Tolvaptan in Children and Adolescents With ADPKD (Autosomal Dominant Polycystic Kidney Disease)
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Primary: Phase A: Change From Baseline in Spot Urine Osmolality (Pre-morning Dose) — 635; 646; -386; -93 milliosmoles per kilogram (mOsm/kg)
Phase 3 N=1,803 Long Term Safety of Immediate-release Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease
Polycystic Kidney, Autosomal Dominant
Primary: Number Of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) — 473; 531; 640; 6 participants
Phase 2 N=51 Feasibility Study of Metformin Therapy in ADPKD
Polycystic Kidney, Autosomal Dominant
Primary: Safety and Tolerability of Metformin — 50; 100; 82; 100 percentage of participants
Phase 4 N=68 Curcumin Therapy to Treat Vascular Dysfunction in Children and Young Adults With ADPKD
Polycystic Kidney, Autosomal Dominant
Primary: Percent Change in Brachial Artery Flow-mediated Dilation (FMD-BA) — 1.14; 0.3 percent change
Phase 3 N=135 A Study to Investigate the Long-term Safety and Efficacy of Tolvaptan in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Trial 156-04-251 in Japan]
Autosomal Dominant Polycystic Kidney Disease （ADPKD)
Primary: Total Kidney Volume — 1812.38; 1878.82; 1934.14; 2214.28 mL
Phase 2 N=177 8-Week Study of Tolvaptan Dose Forms in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Autosomal Dominant Polycystic Kidney Disease
Primary: Percent Change From Baseline in Total Kidney Volume (TKV) at Week 3 — -2.46; -2.55; -1.17; 0.09 Percentage change — p=0.0127
Phase 2 N=80 Study of the Efficacy and Safety of Tesevatinib in Subjects With ADPKD
Autosomal Dominant Polycystic Kidney · ADPKD
Primary: Change From Baseline in Height Adjusted Total Kidney Volume (htTKV) at Month 12 — 0.0236; 0.0288 milliliters per meter — p=0.5265
N/A N=1,802 Post-Marketing Surveillance Study of Tolvaptan in Patients With ADPKD
Polycystic Kidney, Autosomal Dominant
Primary: Estimated Slope of Total Kidney Volume During Pre-administration and Administration — 6.7517; 3.6811 %/year
Phase 3 N=42 Octreotide in Severe Polycystic Liver Disease
Polycystic Kidney, Autosomal Dominant · Polycystic Liver Disease · Hepatomegaly
Primary: Percent Change in Liver Volume — -5.0; 0.9 percent change — p=0.048