Clinical trials: Kidney Insufficiency
Healthy Subjects, Renal Impairments
Pharmacokinetic (PK) Study in Japanese Non-epileptic Renal Impaired Patients
This is a human pharmacology, single-dose study to investigate the pharmacokinetics of orally administered Levetiracetam (LEV) in Japanese subjects with normal renal function and in Japanese subjects with various degrees of…
- Trial name
- NCT01491113
- Testing
- Levetiracetam 250 mg, Levetiracetam 500 mg
- Where
- 2 sites in Japan
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- UCB Pharma
Renal Insufficiency, Acute Kidney Injury
Renal Assist Device (RAD) for Patients With Renal Insufficiency Undergoing Cardiac Surgery
The study is a prospective, non-randomized early feasibility study intended to evaluate the safety and performance of the JuxtaFlow System (also known as the JuxtaFlow Renal Assist Device (RAD)) in participants with pre-existing…
- Trial name
- BIPASS-AKI (NCT05990660)
- Testing
- JuxtaFlow System
- Where
- 3 sites in Poland, Serbia
- Volunteers
- 10 people
- Sponsor
- 3ive Labs
Anemia, Kidney Failure
A Safety and Efficacy Study for Epoetin Alfa in Pre-dialysis Subjects.
The purpose of this study is to determine if using Eprex, to maintain hemoglobin within the normal range, will prevent or delay the progression of left ventricular mass growth.
- Conditions
- Anemia, Kidney Failure, Left Ventricular Hypertrophy
- Trial name
- NCT00364260
- Testing
- epoetin alfa
- Volunteers
- 172 people
- Sponsor
- Janssen-Ortho Inc., Canada
Chronic Kidney Disease
Pharmacokinetics of Verinurad and Allopurinol in Combination With Cyclosporine and Rifampicin in Healthy Volunteers
This Phase 1 study aims to quantify the effects of cyclosporine, a broad transporter inhibitor, and rifampicin, an OATP1B1/3 inhibitor, on verinurad pharmacokinetics (PK).
- Trial name
- NCT04532918
- Testing
- Verinurad, Allopurinol, Cyclosporine
- Where
- Germany
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
End Stage Renal Disease
A Research Study for Patients With End-Stage Renal Disease (ESRD)
The purpose of this study is to evaluate the ability of a treatment strategy, that includes cinacalcet for the management of secondary hyperparathyroidism, to control parathyroid hormone (PTH) compared with the standard of care.
- Trial name
- NCT00110890
- Testing
- cinacalcet, Standard of care
- Volunteers
- 552 people
- Sponsor
- Amgen
Acute Kidney Injury
A Study of THR-184 in Patients at Risk of Developing Cardiac Surgery Associated-Acute Kidney Injury (CSA-AKI)
The purpose of this study is to determine whether THR-184 when administered around the time of cardiac surgery that requires cardiopulmonary bypass can prevent or ameliorate the development of acute kidney injury.
- Trial name
- NCT01830920
- Testing
- THR-184
- Where
- 41 sites in United States, Canada
- Volunteers
- 452 people
- Sponsor
- Thrasos Innovation, Inc.
Cardiac Surgery Associated - Acute Kidney Injury, AKI - Acute Kidney Injury
Safety & Efficacy of RenalGuard® Therapy in the Prevention of Cardiac Surgery Associated Acute Kidney Injury
The goal of this clinical trial is to assess the effect of RenalGuard Therapy in reducing the rates of Acute Kidney Injury (AKI) within 72 hours after cardiac surgery in patients at risk of developing Cardiac Surgery Associated…
- Trial name
- SAFEGUARD (NCT07123935)
- Testing
- RenalGuard® Therapy, Standard of Care (SOC)
- Where
- 2 sites in Malaysia
- Volunteers
- 300 people
- Sponsor
- CardioRenal Systems, Inc.
Healthy
BI 1744 CL in Patients With Severe Renal Impairment in Comparison to Subjects With Normal Renal Function
Study to assess the influence of severe renal impairment on the pharmacokinetics (PK), safety, and selected pharmacodynamic (PD) parameters of BI 1744 CL (30 μg administered by inhalation with the Respimat® Inhaler)
- Trial name
- NCT02172118
- Testing
- BI 1774 CL
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Obesity & Overweight
A Pharmacokinetic Study of VCT220 With Moderate Renal Impairment Patients
This Phase 1 study is designed to evaluate the pharmacokinetics and safety of a single oral dose of VCT220 (other name: CX11) in subjects with moderate renal impairment compared with age-, sex-, and body mass index (BMI)-matched…
- Trial name
- NCT07347808
- Testing
- VCT220
- Where
- China
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Vincentage Pharma Co., Ltd
Chronic Renal Failure
Pharmacodynamics and Non-Clinical Inferiority of Heparin Sodium (Cristália) Compared With the Product Liquemine (Roche) in Chronic Renal Failure
The primary objective of the study was to assess the safety in use of the drug Heparin Sodium, produced by Cristália Laboratory, compared drug Liquemine ®, manufactured by Roche Laboratory, and secondary purpose was to evaluate…
- Trial name
- heparin (NCT00828776)
- Testing
- Heparin sodic - Cristália, heparin - Liquemine (Roche)
- Where
- Brazil
- Volunteers
- 62 people
- Sponsor
- Azidus Brasil
Hypertensive Nephropathy, Auto Immune Disorders
ACE Reno, Pico Cell Matrix and Its Effect on eGFR in Chronic Kidney Diseases
This study investigates the safety and efficacy of ACE Reno, an oral transmucosal solution containing standardized bioactive peptides and amino acids, in patients with nephropathy of various etiologies and stages.
- Conditions
- Hypertensive Nephropathy, Auto Immune Disorders, Chronic Kidney Disease, Chronc Kidney Disease Stage 5
- Trial name
- ACE Reno (NCT07187713)
- Testing
- ACE Reno
- Where
- Egypt
- Volunteers
- 300 people
- Sponsor
- Ace Cells Lab Limited
Anemia
A Phase 2a Study To Evaluate The Pharmacokinetics, Safety, Efficacy, Tolerability, And Pharmacodynamics of Sotatercept (ACE-011) for the Correction of Anemia in Subjects With End-stage Renal Disease on Hemodialysis.
This is the first study in hemodialysis subjects with anemia to evaluate the pharmacokinetics, safety, efficacy, tolerability, and pharmacodynamics of sotatercept (ACE-011)
- Trial name
- NCT01146574
- Testing
- Sotatercept
- Where
- 24 sites in United States
- Volunteers
- 50 people
- Sponsor
- Celgene
Chronic Kidney Disease
A Study to Evaluate the Safety and Pharmacokinetics With MEDI8367 Administered in Healthy Subjects, and in Subjects With Chronic Kidney Disease
This Phase I First in Human (FIH) study is being conducted to determine the safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity profile of MEDI8367 across the dose range.
- Trial name
- NCT04365218
- Testing
- MEDI8367
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Anemia Associated With Chronic Kidney Disease (CKD)
Study Evaluating the Efficacy and Safety of Dose Conversion From a Long-acting Erythropoiesis-stimulating Agent (Mircera®) to Three Times Weekly Oral Vadadustat for the Maintenance Treatment of Anemia in Hemodialysis Subjects
This study will be conducted to demonstrate the efficacy and safety of vadadustat administered three times weekly (TIW) compared to a long-acting erythropoiesis-stimulating agent (ESA) (Mircera®) for the maintenance treatment of…
- Trial name
- NCT04707768
- Testing
- Vadadustat, Mircera®
- Where
- 58 sites in United States
- Volunteers
- 456 people
- Sponsor
- Akebia Therapeutics
End Stage Renal Disease
Monitoring in Dialysis -- a Prospective, Multi-center, Single-arm, Non-randomized, Observational Study in Patients Who Are Undergoing Hemodialysis.
The primary objective of this study is to estimate the proportion of hemodialysis patients experiencing clinically significant cardiac arrhythmias over a 6-month period using continuous cardiac monitoring with an implanted…
- Trial name
- MiD (NCT01779856)
- Testing
- REVEAL Insertable Cardiac Monitor (ICM)
- Where
- 10 sites in United States, India
- Volunteers
- 81 people
- Sponsor
- Medtronic Corporate Technologies and New Ventures
Chronic Kidney Disease
A Phase 1, Open-label Safety Study of NKA in Patients With Type 2 Diabetes
The purpose of this study is to determine if selected renal cells, obtained by biopsy from a patient with chronic kidney disease (CKD) and Type 2 Diabetes (i.e., autologous cells) can be safely implanted back into the patient.
- Trial name
- NCT02008851
- Testing
- Neo-kidney augment
- Where
- 5 sites in United States
- Volunteers
- 1 people
- Sponsor
- Tengion
Respiratory Failure, Respiratory Arrest
Postoperative Respiratory Abnormalities
The study aims to determine how historical cases of respiratory abnormalities are documented by clinicians in the electronic health records (EHR) of Memorial Hermann Healthcare System (MHHS) inpatient facilities.
- Conditions
- Respiratory Failure, Respiratory Arrest, Respiratory Distress Syndrome, Acute Respiratory Failure
- Trial name
- AI-ARF (NCT04079829)
- Testing
- Observational retrospective cohort to describe data validity; and Data reliability; and Completeness of the data
- Where
- United States
- Volunteers
- 50,000 people, healthy volunteers welcome
- Sponsor
- Efficacy Care R&D Ltd
Renal Impairment
Safety, Pharmacokinetics (PK), And Hematological Activity Of AMD3100 (Plerixafor) In Subjects With Renal Impairment
Eligible male and female subjects with renal impairment (aged 18-78 years) and healthy control subjects (aged 35 to 78 years) will be enrolled in the study.
- Trial name
- NCT00445302
- Testing
- plerixafor
- Where
- 3 sites in United States
- Volunteers
- 23 people
- Sponsor
- Genzyme, a Sanofi Company
Anemia in End-Stage Renal Disease
Comparing Efficacy and Safety of CinnaGen Beta Erythropoietin (CinnaPoietin®) Versus Eprex® on the Treatment of Anemia in ESRD Hemodialysis Patients
This Phase III, randomized, two-armed, parallel, double-blind, active-controlled clinical trial is designed to compare efficacy and safety of CinnaPoietin® (Beta erythropoietin) and Eprex® (epoetin alpha) on the treatment of…
- Trial name
- NCT03408639
- Testing
- CinnaPoietin®, Eprex®, Nephrovit
- Where
- 8 sites in Iran
- Volunteers
- 156 people
- Sponsor
- Cinnagen
Renal Impairment
Investigation of the Effects of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of Opemalirsen (AZD2373)
This study is being conducted to investigate the PK, safety, and tolerability of opemalirsen in participants with renal impairment, compared to participants with normal renal function.
- Trial name
- NCT07154901
- Testing
- Opemalirsen (AZD2373)
- Where
- 2 sites in United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
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