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)
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Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
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
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 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=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=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=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 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=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
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=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 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 4 N=511 A Study of the Safety and Tolerance of Regadenoson in Subjects With Renal Impairment
Kidney Diseases · Coronary Artery Disease
Primary: Number of Subject With Serious Treatment Emergent Adverse Events (TEAE) — 0; 0 Subjects
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=36 Pharmacokinetic and Safety Study of Daclatasvir in Patients With Renal Impairment
Hepatitis C
Primary: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Daclatasvir — 11215.264; 21261.199; 24789.951; 21946.450…
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 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 1 N=11 Pharmacokinetic Study of Aztreonam-Avibactam in Severe Renal Impairment
Renal Insufficiency
Primary: Total Daily Area Under the Plasma Concentration-time Profile From Time 0 to 24 Hours at Steady-state (AUC0-24,ss) of Aztreonam (ATM) — 922.9; 733.5 Microgram*hour per…
Phase 1 N=32 Renal Impairment Study of Empagliflozin (BI10773) in Japanese Patients With Type 2 Diabetes
Diabetes Mellitus, Type 2
Primary: Change From Baseline in Total Urinary Glucose Excretion (UGE) — 74969.3; 62577.4; 57889.0; 23725.1 mg
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=29 A Study To Investigate The Pharmacokinetics, Safety And Tolerability Of An Intravenous And Oral Form Of A Compound In Subjects With Varying Degrees Of Renal Impairment And Normal Renal Function
Pneumonia
Primary: Maximum Observed Plasma Concentration (Cmax) of CP-70429 Following CP-70,429 Intravenous Dose — 17700; 22070; 28940; 10340 nanogram per milliliter (ng/mL)
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=16 Study to Compare a Dose of Telotristat Etiprate in Subjects With Renal Impairment With Matched Subjects With Normal Renal Function
Renal Impairment
Primary: Maximum Plasma Concentration (Cmax) of Total Telotristat Ethyl, LP-778902 and LP-951757 — 3.81; 4.94; 533; 759 ng/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=30 Study of Copanlisib in Hepatic or Renal Impairment
Hepatic Insufficiency, Renal Insufficiency
Primary: Maximum Observed Concentration (Cmax) of Copanlisib in Plasma. — 68.12; 71.09; 31.77; 49.20 μg/L
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 1 N=48 Phase I Open-label Study to Evaluate Pharmacokinetics of TAK-272 in Participants With Renal or Hepatic Impairment
Renal Impairment · Hepatic Impairment
Primary: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Free Form of TAK-272 (TAK-272F) and Its…
Phase 1 N=49 A Single-Dose Study to Investigate the Pharmacokinetics of MK-7655 in Participants With Impaired Renal Function (MK-7655-005)
Infectious Disease
Primary: Part 1: Area Under the Plasma Concentration-time Curve From Dosing to Infinity (AUC0-inf) of MK-7655 in Combination With PRIMAXIN® — 73.5; 45.0; 115; 52.3 µM*hr
Phase 1 N=40 Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BI 10773 in Type II Diabetes Patients With Different Degrees of Renal Impairment
Diabetes Mellitus, Type 2
Primary: AUC0-∞ (Area Under the Concentration Time Curve of the Analyte in Plasma Over the Time Interval From 0 to Infinity) — 10500; 12400; 12600; 17500 nmol*h/L
Phase 1 N=16 A Study Evaluating the Pharmacokinetics of Doravirine (MK-1439) in Participants With Severe Renal Impairment (MK-1439-051)
Renal Impairment
Primary: Area Under the Plasma Concentration Versus Time Curve From 0 Hours to Infinity (AUC0-∞) of Doravirine — 64.5; 45.1 μM•hr