Phase 3 N=65 Hyper- and Hypokalemic Periodic Paralysis Study
Hyperkalemic Periodic Paralysis · Hypokalemic Periodic Paralysis
Primary: HYP Attack Rate — 0.9; 4.8 attacks per week
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Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
N/A N=240 POtassium and Cardiac Rhythm Trends in MaintENance HemoDialysis: A Multicenter, Prospective, Observational Study
Hyperkalemia
Primary: Incidence of Pre-dialysis HK After the LIDP in <3K Dialysate Patients — 50; 37 Percent of participants
Phase 4 N=43 Relypsa For ED Acute Hyperkalemia Control and Reduction (REDUCE)
Kidney Failure, Chronic
Primary: Efficacy of Patiromer in Reducing Serum Potassium — 6.17; 6.6; 5.9; 6.47 mEq/L
Phase 4 N=33 Patiromer Efficacy to Reduce Episodic Hyperkalemia in End Stage Renal Disease Patients
Hyperkalemia · End Stage Renal Disease
Primary: Total Number of Episodes of Serum Potassium ≥ 5.5 mEq/L — 13; 41 episodes — p=0.024
Phase 3 N=243 A Two-Part, Single-Blind, Phase 3 Study Evaluating the Efficacy and Safety of Patiromer for the Treatment of Hyperkalemia (OPAL)
Chronic Kidney Disease (CKD) · Hyperkalemia (HK)
Primary: Change in Serum Potassium From Part A Baseline to Part A Week 4 — -1.01 mEq/L — p=<0.001
Phase 2 N=27 The Effects of Patiromer on Serum Potassium Level and Gut Microbiome of ESRD Patients With Hyperkalemia
ESRD · Hyperkalemia · End Stage Renal Disease
Primary: Adverse Events of Participants Taking Patiromer in Lowering Serum Potassium Levels in End Stage Renal Disease (ESRD) Patients With Hyperkalemia Measured by…
Phase 2 N=29 The Effects of Potassium on Glucose Metabolism in African Americans
Borderline Hypokalemia
Primary: Change in Glucose Tolerance as Measured by Area-under-the-curve — 328; 1000 AUC - mg*min/dL — p=0.5582
Phase 4 N=114 Patiromer With or Without Food for the Treatment of Hyperkalemia
Hyperkalemia
Primary: Percentage of Subjects With Serum Potassium in the Target Range (3.8 - 5.0 mEq/L) at Either Week 3 or Week 4 — 82.5; 87.3 percentage of participants
Phase 2 N=4 Mexiletine for Muscle Cramps in Charcot Marie Tooth Disease
Charcot Marie Tooth Disease
Primary: Number of Participants With a Decrease in Cramp Duration — 2; 0 participants
Phase 2 N=13 Effect of Dalfampridine (4-AP) on Genioglossus Muscle Activity in Healthy Adults
Sleep Apnea, Obstructive
Primary: Genioglossus Activity During Sleep Expressed as %Wakefulness Value (Before Drug/Placebo Administration). — 166; 136; 245; 163 percentage of wakefulness value — p=0.85
Phase 4 N=3 Use of Patiromer to Transition Chronic Kidney Disease Patients With Hyperkalemia to a Plant-rich Diet.
Chronic Kidney Diseases · Hyperkalemia
Primary: Change in Fasting Serum Potassium Concentrations — -0.2 mg/dL
Phase 2 N=59 Effectiveness of Mexiletine for Treating People With Non-Dystrophic Myotonia
Myotonia · Non-Dystrophic Myotonia
Primary: Patient-reported Stiffness on the IVR — 2.53; 4.21; 1.60; 5.27 units on a scale — p=<0.001
Phase 2 N=63 Evaluation of Patiromer Titration in Heart Failure Patients With Chronic Kidney Disease
Heart Failure
Primary: Percentage of Participants With Serum Potassium in the Range of 3.5 - 5.5 mEq/L at the End of Treatment — 90.5 percentage of participants
Phase 2 N=70 A Study to Evaluate a Potassium Normalization Treatment Regimen Including Sodium Zirconium Cyclosilicate (ZS) Among Patients With S-K ≥5.8
Hyperkalemia
Primary: Mean Absolute Change in S-K From Baseline Until 4h After Start of Dosing With SZC/Placebo — -0.41; -0.27 mmol/L
Phase 1 N=60 CiPA Phase 1 ECG Biomarker Validation Study
Drug-induced QT Prolongation · Pharmacokinetics · Pharmacodynamics
Primary: Change From Baseline J-Tpeakc With "Balanced Ion Channel" Drugs (Ranolazine, Verapamil, Lopinavir / Ritonavir) — -8.3; -7.8; -11.5; -10.9 ms
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
Phase 2 N=132 AZP-3601 SAD and MAD Study in Healthy Subjects and Patients With Hypoparathyroidism
Chronic Hypoparathyroidism
Primary: Treatment Emergent Adverse Events (TEAEs) — 2; 3; 5; 1 Participants
Phase 3 N=754 Safety & Efficacy of Zirconium Silicate in Mild to Moderate Hyperkalemia
Hyperkalemia
Primary: Exponential Rate of Change in Serum Potassium (S-K) Levels During the Initial 48 Hours of Study Drug Treatment. — -0.00128; -0.00187; -0.00205; -0.00280 log(mmol/L)/hour
Phase 3 N=103 ZS Ph2/3 Dose-response Study in Japan
Hyperkalemia
Primary: Exponential Rate of Change in Serum Potassium (S-K) Values During the Initial 48 Hours of Study Drug Treatment — -0.00273; -0.00508; -0.00012 log (mmol/L) / hour…
Phase 3 N=1,195 Patiromer for the Management of Hyperkalemia in Subjects Receiving RAASi Medications for the Treatment of Heart Failure (DIAMOND)
Hyperkalemia
Primary: Changes in Serum K+ Levels From Baseline — 0.029; 0.127 Milliequivalents Per Liter (mEq/l) — p=< 0.001
Phase 2 N=105 Evaluation of Patiromer in Heart Failure Patients
Hyperkalemia · Heart Failure
Primary: Change From Baseline in Serum Potassium to the End of the 28-day Treatment Period. — -0.21; 0.23 mEq/L — p=< 0.001