Phase 1 N=31 Mild, Moderate and Severe Renal Impairment Study
Gout
Primary: Maximum Observed Plasma Concentration (Cmax) — 25.6; 29.0; 38.2; 16.7 ng/mL
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 1 N=23 A Renal Impairment Study for PF-04965842
Renal Impairment
Primary: Maximum Observed Plasma Concentration (Cmax) for PF-04965842 — 1174; 1626; 1164 nanogram per milliliter (ng/mL)
Phase 1 N=32 PF-04634817 Renal Impairment Study
Renal Insufficiency
Primary: Area Under the Curve From Time Zero to 48 Hours[AUC (0 - 48)] — 1294; 1399; 2024; 2860 Nanogram*hour/milliliter (ng*h/mL)
Phase 1 N=24 Pharmacokinetics Of CP-690,550 In Patients With Impaired Renal Function
Renal Impairment
Primary: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] — 268; 370; 396; 615 nanogram*hour/milliliter (ng*hr/mL)
Phase 1 N=42 Pharmacokinetics (PK) of Dalfampridine-ER 7.5 mg BID in Healthy Volunteers and Subjects With Mild or Moderate Renal Impairment
Renal Insufficiency
Primary: The Steady State Area Under the Drug Concentration Time Curve From 0 to 12 Hours Post Dose AUC(0-12). — 157.8; 276.5; 415.3 hour*nanogram/milliliter
Phase 1 N=18 A Study of MK-8527 in Participants With Moderate and Severe Renal Impairment (MK-8527-008)
Renal Impairment
Primary: Area Under the Concentration Versus Time Curve From Time 0 to Last Quantifiable Sample (AUC0-last) of MK-8527 in Plasma — 769; 1160; 1430 nM·hr
Phase 1 N=27 Renal Impairment Study of PF-07321332 Boosted With Ritonavir in Adult Participants With Renal Impairment and in Healthy Participants With Normal Renal Function.
Renal Impairment
Primary: Maximum Observed Plasma Concentration (Cmax) of PF-07321332 — 1600; 2077; 2210; 2369 Nanogram per milliliter
Phase 1 N=30 Pharmacokinetics Study of MCI-186 in Subjects With Mild or Moderate Renal Impairment
Renal Impairment · Healthy
Primary: Cmax — 545.4; 593.2; 475.9 ng/mL
Phase 3 N=106 Cobicistat-containing Highly Active Antiretroviral Regimens in HIV-1 Infected Patients With Mild to Moderate Renal Impairment
Acquired Immunodeficiency Syndrome · HIV Infections
Primary: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) Using the Cockcroft-Gault (CG) Equation at Week 24 (Cohort 1) — 72.9; -5.2 mL/min
Phase 1 N=32 Pharmacokinetics of LCZ696 in Subjects With Mild and Moderate Renal Impairment Compared to Healthy Subjects With Normal Renal Function
Mild and Moderate Renal Impairment
Primary: Time to Reach Maximum Peak Plasma Concentration (Tmax) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5) — 1; 0.5; 0.5; 0.5 hr
Phase 1 N=18 A Study of Enlicitide Chloride (MK-0616 Oral PCSK9 Inhibitor) in Participants With Moderate Renal Impairment (MK-0616-007)
Moderate Renal Impairment
Primary: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-Inf) of MK-0616 — 453; 369 hour*nmol/Liter
Phase 1 N=32 Pharmacokinetics and Safety of BI 201335 in Patients With Mild to Severe Renal Impairment
Hepatitis C
Primary: AUC0-∞ — 76500; 86900; 136000; 129000 ng*h/mL
Phase 1 N=29 Lorlatinib Renal Impairment Study
Renal Impairment
Primary: Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of Lorlatinib — 8329; 8683; 9890; 11760 ng*hr/mL
Phase 1 N=24 A Study to Evaluate the Effects of Renal Impairment on the Pharmacokinetics of ELX-02
Impaired Renal Function
Primary: Pharmacokinetic Parameters- Plasma AUC0-24 — 16877.94; 32787.41; 64895.29; 15506.68 ng*h/mL
Phase 1 N=25 Pharmacokinetics of Peginterferon Alfa-2b in Participants With Moderate and Severe Renal Impairment (P05655)
Renal Insufficiency
Primary: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞) — 305315.22; 435500.38; 658413.69 pg*hr/mL
Phase 1 N=23 Safety, Pharmacokinetics (PK), And Hematological Activity Of AMD3100 (Plerixafor) In Subjects With Renal Impairment
Renal Impairment
Primary: Dose-Normalized Maximum Concentration of Plerixafor (Cmax) — 0.0452; 0.0388; 0.0490; 0.0475 ng/mL/ug
N/A N=2,120 Dabigatran Etexilate for Stroke Prevention in Patients With Atrial Fibrillation and Mild to Moderate Renal Impairment
Atrial Fibrillation
Primary: Creatinine Clearance (Recalculated Using Entries of Age, Gender, Body Weight and Serum Creatinine Made by the Physician) — 55.2 ml/min
Phase 4 N=60 Pradaxa Study in Non-valvular Atrial Fibrillation Patients With Severely Impaired Renal Function
Atrial Fibrillation
Primary: Pre-dose Concentration of the Analyte in Plasma at Steady State Immediately Before Administration of the Next Dose — 155 ng/mL
Phase 1 N=46 A Study to Assess Pharmacokinetics (PK) of Preladenant in Participants With Chronic Renal Impairment (CRI) (P06512)
Parkinson Disease
Primary: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞) After Single Dosing With Preladenant for Participants With Severe CRI Versus Healthy Matched…
Phase 1 N=30 Renal Impairment Study of PF-06700841
Healthy Volunteer · Renal Impairment
Primary: Maximum Observed Plasma Concentration (Cmax) of PF-06700841 Following Single Oral Dose Administration in Participants With Renal Impairment and in Healthy Participants…
Phase 4 N=40 Healthy and Renal Impairment Study of Colcrys (Colchicine, USP)
Pharmacokinetics
Primary: Maximum Plasma Concentration (Cmax) — 2.43; 2.73; 3.69; 2.53 ng/mL
Phase 1 N=16 Pharmacokinetics of MK-3682B in Participants With Moderate to Severe Renal Insufficiency (MK-3682B-030)
Hepatitis C
Primary: Area Under the Plasma Concentration-time Curve (AUC) From Dosing to Time of Last Measurable Concentration (AUC0-last) of Uprifosbuvir (MK-3682) — 8.55; 4.23 uM*hr
Phase 2 N=83 A Study of CSL112 in Adults With Moderate Renal Impairment and Acute Myocardial Infarction
Acute Myocardial Infarction · Moderate Renal Impairment
Primary: Percent of Participants With at Least One Occurrence of Treatment-emergent Renal Serious Adverse Events (SAEs) (SAF) — 1.9; 14.3 percentage of participants
Phase 3 N=252 Open-label Safety Study of E/C/F/TAF (Genvoya®) in HIV-1 Positive Patients With Mild to Moderate Renal Impairment
HIV · HIV Infections
Primary: Change From Baseline in the Estimated Glomerular Filtration Rate Calculated by the Cockcroft-Gault Formula (eGFR_CG) at Week 24 — 55.6; 60.2; -0.4; -0.3 mL/min
Phase 4 N=32 An Open-label, Non-randomized, Parallel Group Study in Subjects With Mild, Moderate, Severe, or No Renal Impairment
Renal Impairment
Primary: Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide — 37.1; 33.4; 43.3; 30.6 μg/mL
Phase 1 N=33 Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Renal Impairment Study (MK-0616-020)
Hypercholesterolaemia
Primary: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-Inf) of Enlicitide Decanoate — 733; 554; 850; 570 hr*nmol/Liter
Phase 1 N=32 Pharmacokinetics of Midazolam, Dabigatran, Pitavastatin, Atorvastatin, and Rosuvastatin in Participants With Renal Insufficiency in the Presence and Absence of Rifampin (MK-0000-386)
Renal Insufficiency
Primary: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) Post-dose Period 1 — 110; 260; 364; 176 pg*hr/mL
Phase 1 N=20 A Study in People With Normal Kidney Function and People With Reduced Kidney Function to Test How BI 1467335 is Processed in the Body
Renal Insufficiency · Healthy
Primary: Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Time Interval From 0 to 24 Hours After Administration of the First Dose (AUC0-24) — 3.97; 7.88…
Phase 4 N=18 Pharmacokinetics, Safety And Toleration Of Maraviroc Administered To Subjects With Various Degrees Of Renal Impaired And Normal Renal Function
Human Immunodeficiency Virus (HIV) Infection
Primary: Area Under the Plasma Concentration Time-curve From Zero to the Last Measured Concentration (AUClast) — 7356.3; 9502.1; 6496.0; 1320.7 ng*hr/mL
Phase 4 N=57 Kidney Damage in Patients With Moderate Fall in eGFR
Coronary Artery Stenosis
Primary: Impact on the Trajectory of Serum and Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) Following Administration — -27.76; -11.11; -11.84; -8.23 ng/mL