Clinical trials: Kidney Failure,Chronic
Kidney Diseases, Renal Insufficiency, Chronic
The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of FAST PV and mGFR Technology™
This is a Phase 2b, prospective, open-label study designed to evaluate the safety, tolerability, PK, and PD of FAST PV and mGFR Technology in healthy subjects and patients with varying degrees of renal impairment.
- Conditions
- Kidney Diseases, Renal Insufficiency, Chronic, Acute Kidney Injury, Urologic Diseases
- Trial name
- NCT03095391
- Testing
- VFI, Iohexol
- Where
- 2 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- FAST BioMedical
End-stage Renal Disease (ESRD)
A Study of Safety, PK, & PD of ISIS 416858 Administered Subcutaneously to Patients With End-Stage Renal Disease on Hemodialysis
Evaluation of safety, tolerability, PK and PD of ISIS 416858 in patients with end-stage renal disease (ESRD) receiving chronic hemodialysis.
- Trial name
- NCT02553889
- Testing
- ISIS 416858
- Where
- 8 sites in Canada
- Volunteers
- 49 people
- Sponsor
- Ionis Pharmaceuticals, Inc.
Chronic Kidney Disease (CKD)
Observational Secondary Data Study Describing Treatment With Dapagliflozin Among Adult Chronic Kidney Disease Patients
The OPTIMISE-CKD CEE study design will create a real-world evidence platform that systematically leverages the routine data collection made by Investigators and will help obtain relevant insights from clinical practice.
- Trial name
- OPTIMISE-CKD (NCT06203704)
- Where
- 56 sites in Bulgaria, Croatia and 5 more
- Volunteers
- 1,086 people
- Sponsor
- AstraZeneca
Hyperphosphatemia, End Stage Renal Disease
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Effects of Ferric Citrate in Subjects With End Stage Renal Disease
The purpose of the study is to determine the effect and optimum dose and evaluate the safety of ferric citrate, administered three times daily (TID) immediately after meals for a total daily dose of 4 or 6 grams for 56 days, on…
- Conditions
- Hyperphosphatemia, End Stage Renal Disease, ESRD
- Trial name
- NCT01503736
- Testing
- ferric citrate
- Where
- 5 sites in Taiwan
- Volunteers
- 183 people
- Sponsor
- Panion & BF Biotech Inc.
Anemia, Anaemia
Study to Evaluate the Safety and Efficacy of GSK1278863 in Recombinant Human Erythropoietin (rhEPO) Hyporesponsive Hemodialysis-dependent Chronic Kidney Disease Subjects With Anemia
The study will evaluate the ability of GSK1278863 to increase the hemoglobin (Hgb) concentration, or maintain it within the target range, and the safety and efficacy of GSK1278863 over 16 weeks of treatment, in…
- Trial name
- NCT02075463
- Testing
- GSK1278863
- Where
- 10 sites in United States
- Volunteers
- 15 people
- Sponsor
- GlaxoSmithKline
End-Stage Renal Disease Requiring Haemodialysis
To Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of KN060 in ESRD Dialysis Patients
The primary objective of this study is to assess the safety and tolerability of KN060 in patients with end-stage renal disease on regular hemodialysis.
- Trial name
- NCT07201467
- Testing
- KN060
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Suzhou Alphamab Co., Ltd.
Renal Insufficiency, Chronic, Hepatic Insufficiency
Open-Label, Single-Dose Study to Evaluate the Safety and PK of DIC075V in Subjects With Renal Insufficiency and Hepatic Impairment Compared to Healthy Subjects and Evaluate the Safety and Pharmacokinetics of HPβCD When Administered in DIC075V Compared to Sporanox® in Healthy Subjects
An open-label, single-dose study to evaluate the safety and pharmacokinetics of DIC075V in subjects with mild or moderate chronic renal insufficiency and in patients with mild chronic hepatic impairment compared.
- Conditions
- Renal Insufficiency, Chronic, Hepatic Insufficiency, Healthy
- Trial name
- NCT00805090
- Testing
- Sporanox, Diclofenac Sodium
- Where
- 4 sites in United States, United Kingdom
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Javelin Pharmaceuticals
Chronic Kidney Diseases, Kidney Injury, Acute
Clinical Performance of a Point-of-Care Creatinine Testing System in Individuals With Kidney Disease
The goal of this clinical performance study is to evaluate the accuracy and usability of the Eaglenos Creatinine Test System（referred to as EG）, a point-of-care testing (POCT) system that consists of a handheld device and its…
- Trial name
- NCT07251075
- Testing
- Reference Creatinine Test System（Cobas c 111）, Investigational Creatinine Test System （EG）
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Tingting Xu
Myelofibrosis
PK of Pacritinib in Patients With Mild, Moderate, Severe Renal Impairment and ESRD Compared to Healthy Subjects
This is a Phase 1 open label, single dose, 5 parallel-group study in which a single 400 mg dose of pacritinib will be administered orally to patients with renal impairment (mild, moderate, severe, and patients with ESRD requiring…
- Trial name
- NCT02807077
- Testing
- Pacritinib
- Where
- 3 sites in Germany, Moldova and 1 more
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- CTI BioPharma
End Stage Renal Disease
Pharmacokinetics, Safety and Tolerability of Aliskiren (SPP100) in Patients With End Stage Renal Disease on Hemodialysis and Matched Healthy Subjects
This study will assess the pharmacokinetics, safety and tolerability of aliskiren in healthy subjects and patients with End Stage Renal Disease on hemodialysis.
- Trial name
- NCT01568775
- Testing
- Aliskiren
- Where
- Germany
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Novartis
Kidney Diseases, Kidney Diseases, Chronic
Open-label Extension Study of Zigakibart in Adults With IgA Nephropathy.
The purpose of this study is to determine if zigakibart is safe and effective for long-term use in patients with immunoglobulin A nephropathy (IgAN).
- Conditions
- Kidney Diseases, Kidney Diseases, Chronic, Urological Diseases, Glomerulonephritis
- Trial name
- NCT06858319
- Testing
- zigakibart
- Where
- 26 sites in United States, Argentina and 7 more
- Volunteers
- 220 people
- Sponsor
- Novartis Pharmaceuticals
Bullous Pemphigoid (BP), Cold Agglutinin Disease (CAD)
Safety, Tolerability and Activity of BIVV009 in Healthy Volunteers and Patients With Complement Mediated Disorders
Prospective, double-blind, randomized, placebo-controlled First-In-Human study with four sub-parts: Part A, a single ascending dose study (SAD) in normal human volunteers (NHVs), Part B, a multiple ascending dose study (MAD) in…
- Conditions
- Bullous Pemphigoid (BP), Cold Agglutinin Disease (CAD), Warm Autoimmune Hemolytic Anemia (WAIHA), End-stage Renal Disease (ESRD)
- Trial name
- BIVV009-01 (NCT02502903)
- Testing
- BIV009
- Where
- Austria
- Volunteers
- 122 people, healthy volunteers welcome
- Sponsor
- Bioverativ, a Sanofi company
Iron Deficiency Anemia
A Trial of Ferumoxytol for the Episodic Treatment of Iron Deficiency Anemia in Pediatric Participants With Chronic Kidney Disease
Study AMAG-FER-CKD-253 is an extension study of the combined AMAG-FER-CKD-251 (NCT01155375) and AMAG-FER-CKD-252 (NCT01155388) studies to evaluate the efficacy and safety of episodic treatment of iron deficiency anemia (IDA) with…
- Trial name
- NCT01264679
- Testing
- Ferumoxytol
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- AMAG Pharmaceuticals, Inc.
Chronic Kidney Diseases
A Study to Explore the Renal Safety of Visipaque Injection 320 mgI/mL in Patients With Chronic Kidney Disease
This parallel-group, randomized, placebo-controlled study will examine the incidence and severity of acute kidney injury (AKI) in patients with chronic kidney disease (CKD) stage III/IV following an i.v.
- Trial name
- NCT03119662
- Testing
- Visipaque
- Where
- 29 sites in United States, Belgium and 4 more
- Volunteers
- 4 people
- Sponsor
- GE Healthcare
Renal Failure, End Stage Renal Disease
Safety and Clinical Performance of a Dialyzer With a Modified Polysulfone Membrane
The clinical investigation will be performed to generate clinical data on clearances and removal rates (for ß2-microglobulin, myoglobin, phosphate, creatinine, and urea) as well as biocompatibility of the modified polysulfone…
- Trial name
- eMPORA (NCT03315624)
- Testing
- Dialyzer
- Where
- Germany
- Volunteers
- 49 people
- Sponsor
- Fresenius Medical Care Deutschland GmbH
Kidney Disease
Aranesp® Monthly Preference Study - 2
The purpose of this study was to evaluate subject preference for Aranesp® administered once monthly (i.e., every 4 weeks (Q4W)) or Procrit® administered once weekly (QW).
- Trial name
- NCT00117078
- Testing
- Aranesp®
- Sponsor
- Amgen
Chronic Kidney Disease
Open-label Pharmacokinetic Study of Iron Isomaltoside 1000 (Monofer®) Administered as Single Bolus Injections in Subjects With Stage 5 Chronic Kidney Disease on Dialysis Therapy (CKD-5D)
The purpose of this study is to assess Pharmakokinetic properties of iron isomaltoside 1000 (Monofer®) in doses of 100 mg, 200 mg or 500 mg in subjects with Stage 5 Chronic Kidney Disease on Dialysis Therapy (CKD-5D).
- Trial name
- NCT01469078
- Testing
- Monofer®
- Volunteers
- 18 people
- Sponsor
- Pharmacosmos A/S
Chronic Kidney Disease
Study to Collect Samples for MIST Analysis of Zibotentan and Bioavailability of Zibotentan and Dapagliflozin in Heatlhy Participants
The study will have 2 independent parts: Part 1 of the study is intended to collect samples for Metabolites in Safety Testing (MIST) analysis after administration of multiple doses of zibotentan.
- Trial name
- NCT04991571
- Testing
- Zibotentan (Treatment A), Dapagliflozin (Treatment A), Zibotentan/Dapagliflozin - Formulation 1 (Treatment B)
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
ESRD, Diabetes
IMPENDIA- PEN VS Dianeal Only Improved Metabolic Control In Diabetic CAPD and APD Patients
Primary Objective: To demonstrate that use of glucose sparing prescriptions (PEN vs Dianeal) in diabetic (Type 1 and Type 2) Continuous Ambulatory Peritoneal Dialysis (CAPD)and Automated Peritoneal Dialysis (APD) patients leads…
- Trial name
- Impendia (NCT00567398)
- Testing
- Dianeal, Physioneal, Extraneal
- Where
- 16 sites in Australia, Canada and 1 more
- Volunteers
- 43 people
- Sponsor
- Vantive Health LLC
Renal Replacement Therapy
Blood Viscosity, End-Stage Renal Disease, And Mortality (BEAM-1)
Prospective, real-time observational study of hemodialysis patients treated with erythropoiesis-stimulating agents (ESA) to currently recommended Hgb targets.
- Trial name
- BEAM-1 (NCT01023893)
- Volunteers
- 400 people
- Sponsor
- ProMetrics, Inc.
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