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 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=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 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=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=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=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
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=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=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=24 Pharmacokinetics and Safety of Regorafenib (BAY73-4506) in Cancer Subjects With Severe Renal Impairment
Neoplasms
Primary: AUC(0-tlast) [Area Under the Concentration-time Curve After Single (First) Dose From Time Zero to the Last Data Point >LLOQ (Lower Limit of Quantification)] for…
Phase 1 N=18 Estimation Study to Assess the Effect of Severe Renal Impairment and End-stage Renal Disease Hemodialysis on the Pharmacokinetics of Evolocumab
Hyperlipidemia · Mixed Dyslipidemia
Primary: Maximum Observed Serum Concentration (Cmax) of Evolocumab — 21.3; 15.1; 11.7 μg/mL
Phase 1 N=16 PK and PD Study of IDN-6556 in Subjects With Severe Renal Impairment and Matched Healthy Volunteers
Renal Impairment · Renal Insufficiency · Kidney Disease
Primary: AUC — 102.0; 168.9; 107.4; 188.5 h*ng/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=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=12 PK Study in Subjects With Severe Hepatic Impairment
Severe Hepatic Impairment · Healthy
Primary: Pharmacokinetic Parameters of MCI-186: Peak Drug Concentration (Cmax) — 347.6; 280.3 ng/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 2 N=12 Multiple Dose Pharmacokinetics of LCZ696 and Its Metabolites in Subjects With Severe Renal Impairment vs. Matched Healthy Subjects With Normal Renal Function
Pharmacokinetics · Renal Impaired · Healthy Volunteer
Primary: Time to Reach Maximum Peak Plasma Concentration (Tmax) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5) — 0.5; 0.5; 0.5; 0.5 hour
Phase 3 N=93 Safety and Pharmacokinetics Study of DU-176b Administered to Non-valvular Atrial Fibrillation With Severe Renal Impairment
Non-valvular Atrial Fibrillation
Primary: Incidence of Any Adjudicated Bleeding Events — 20.0; 22.7; 23.8 percentage of subjects with bleeds
Phase 1 N=16 Evaluate Severe Hepatic Impairment on Dacomitinib PK
Severe Hepatic Impairment
Primary: Maximum Observed Plasma Concentration (Cmax) of Dacomitinib — 9.673; 7.389 nanogram per milliliter
Phase 1 N=11 Safety, Tolerability, and Pharmacokinetics of KBP-5074 Following Oral Administration in Chronic Kidney Disease
Chronic Kidney Disease
Primary: Number of Participants With Treatment-related Adverse Events — 0 Participants
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 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=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=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=12 Pharmacokinetics of Islatravir in Participants With Severe Renal Impairment (MK-8591-026)
Human Immunodeficiency Virus (HIV) Infection
Primary: Area Under the Curve From Time 0 to Infinity (AUC0-inf) of Plasma Islatravir (ISL) — 14.4; 6.54 hr*μM
Phase 1 N=19 Study to Evaluate the Pharmacokinetics of Velpatasvir in Participants With Normal Renal Function and Severe Renal Impairment
Hepatitis C Virus
Primary: Pharmacokinetic (PK) Parameter of Velpatasvir: AUClast — 5597.8; 7971.7 h*ng/mL
Phase 1 N=9 Imipenem-Relebactam Pharmacokinetics in Augmented Renal Clearance
Sepsis
Primary: Imipenem Clearance — 17.31 L/h
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