Clinical trials: Renal Insufficiency
Bacterial Infections
PK & Safety Study of Xeruborbactam Oral Prodrug Combined With Ceftibuten in Participants With Renal Impairment
A Phase 1, open-label, single-dose study to determine the safety and pharmacokinetics of ORAvance (ceftibuten/xeruborbactam oral prodrug [QPX7831]) in participants with renal impairment
- Trial name
- NCT06157242
- Testing
- Xeruborbactam Oral Prodrug, Ceftibuten
- Where
- 2 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Qpex Biopharma, Inc.
Renal Impairment
A Study of S-892216-PO in Participants With Renal Impairment and Matched Controls
The purpose of this study is to measure the pharmacokinetics, safety, and tolerability of S-892216 (S-892216-PO) in participants with mild, moderate, or severe renal impairment not on dialysis, or renal impairment requiring…
- Trial name
- NCT07217886
- Testing
- S-892216-PO
- Where
- 4 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Shionogi
Dialysis, Chronic Renal Failure
A Study to Demonstrate the Safety and Effectiveness of the NIKKISO DBB-EXA ES Hemodialysis Delivery System
The study objective is to verify the safety and effectiveness of the DBB-EXA ES Hemodialysis Delivery System to consistently deliver dialysate of the appropriate quality for infusion.
- Trial name
- HEMO (NCT04655989)
- Testing
- DBB-EXA ES Hemodialysis System
- Where
- 2 sites in United States
- Volunteers
- 31 people
- Sponsor
- Nikkiso America, Inc.
Pharmacodynamics
Pharmacodynamics Aspects Of Porcine Heparin Sodium, Produced by Eurofarma, Compared Heparin Sodium, Produced by APP Pharmaceuticasls, in Patients With Chronic Renal Failure
1. Background: Heparin forms a complex with a plasma protein, antithrombin III (ATIII) is an endogenous anticoagulant. This complex inhibits the formation of thrombin and accelerates its destruction.
- Trial name
- NCT01034488
- Testing
- Suine
- Volunteers
- 128 people
- Sponsor
- Azidus Brasil
Chronic Kidney Disease, End-stage Renal Disease
MONITOR-CKD5 - Multi-level Evaluation of Anaemia Treatment, Outcomes, and Determinants in Chronic Kidney Disease Stage 5
MONITOR-CKD5 is an observational, pharmaco-epidemiological study to evaluate the multi-level factors and outcomes associated with the treatment of renal anaemia with biosimilar epoetin alfa in Stage 5 CKD patients requiring…
- Conditions
- Chronic Kidney Disease, End-stage Renal Disease, Anaemia
- Trial name
- MONITOR-CKD5 (NCT01121237)
- Testing
- Recombinant human erythropoietin alfa (biosimilar)
- Where
- 95 sites in Austria, France and 8 more
- Volunteers
- 2,086 people
- Sponsor
- Sandoz
ACS - Acute Coronary Syndrome
Evaluate the Effects of Renal Impairment on the Pharmacokinetics and Pharmacodynamics
The study is a multicenter, Phase 1, open-label, sequential, adaptive, single dose, PK/PD study in subjects with moderate and severe RI and healthy volunteers (HV).
- Trial name
- NCT05323136
- Testing
- MT1002 for Injection
- Where
- United States
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- Shaanxi Micot Pharmaceutical Technology Co., Ltd.
Renal Impairment
Evaluation of Effect of Renal Impairment on the PK of Tenofovir Exalidex
This is a Phase 1 study to investigate the effects of Renal Impairment on the pharmacokinetics of Tenofovir exalidex
- Trial name
- NCT03284164
- Testing
- Tenofovir Exalidex (TXL)
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- ContraVir Pharmaceuticals, Inc.
Diabetic Kidney Disease, Chronic Kidney Disease Stage 1
Prospective Decision Impact Trial of KidneyIntelX
The current trial is designed to evaluate how the results of KidneyIntelX test / platform impacts on the clinical management of type 2 diabetes patients identified as increased risk for rapid kidney function decline within…
- Conditions
- Diabetic Kidney Disease, Chronic Kidney Disease Stage 1, Chronic Kidney Disease Stage 2, Chronic Kidney Disease, Stage 3 (Moderate)
- Trial name
- NCT04960514
- Testing
- KidneyIntelX
- Where
- United States
- Volunteers
- 2,000 people
- Sponsor
- Renalytix AI, Inc.
Complicated Urinary Tract Infection; Cuti
Pharmacokinetics of Benapenem in Subjects With Renal Impairment
This is an open-label, multiple center, parallel-group Study to compare the pharmacokinetics and safety of single-dose benapenem (1.0mg) in subjects with mild or moderate Renal Impairment(RI) and healthy subjects.
- Trial name
- NCT04476407
- Testing
- benapenem
- Where
- China
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Sihuan Pharmaceutical Holdings Group Ltd.
Renal Failure, Cardiovascular Diseases
HaemoDialysis Interventions to REduce Multi-Organ Dysfunction and Effect on Quality of Life Assessed by MRI Scanning
The purpose of this study is to characterise in detail cardiac, cerebral and renal structure, function and perfusion in patients on haemodialysis (HD) using magnetic imaging techniques.
- Conditions
- Renal Failure, Cardiovascular Diseases, Congenital Disorders
- Trial name
- HD-REMODEL (NCT03280901)
- Testing
- HD, Magnetic Resonance Imaging (MRI) scans
- Where
- United Kingdom
- Volunteers
- 17 people
- Sponsor
- Fresenius Medical Care Deutschland GmbH
Hyperplasia, Chronic Renal Failure
Prevention of Vascular Access Graft Failure in Patients With Chronic Renal Failure Requiring Hemodialysis
The purpose of this study is to determine the effect of recipient vein pretreatment of edifoligide (E2F Decoy), compared to placebo, on graft/recipient vein stenosis in polytetrafluoroethylene (PTFE) vascular access grafts placed…
- Trial name
- NCT00086164
- Testing
- edifoligide (E2F Decoy)
- Where
- 21 sites in United States
- Sponsor
- Anesiva, Inc.
Kidney Failure, Chronic
Clinical Study to Assess the Performance of the Dialyzer With Endexo™
Endexo™ is an additive that is blended into the fiber solution during manufacturing of the hemodialyzer hollow fibers. The intended purpose of the additive is to increase blood compatibility in the finished dialyzer, which is…
- Trial name
- NCT03536663
- Testing
- Optiflux and Dialyzer with Endexo
- Where
- 3 sites in United States
- Volunteers
- 23 people
- Sponsor
- Fresenius Medical Care North America
Type 2 Diabetic Nephropathy
Evaluate the Efficacy and Safety of DWP16001 in Type 2 Diabetic Nephropathy with Moderate Renal Impairment Patients
This study aims to evaluate the efficacy and safety of DWP16001 in type 2 diabetic nephropathy with moderate renal impairment patients (CKD stage 3)
- Trial name
- NCT06606093
- Testing
- DWP16001 0.3mg
- Where
- South Korea
- Volunteers
- 348 people
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
Solid Tumours
Study to Assess Osimertinib in Patients w/ Adv Solid Tumours & Normal Kidney Function or Severe Kidney Impairment
The purpose of this study is to assess the effect of severe renal impairment on the levels of AZD9291 in the blood in patients with advanced solid tumours compared to patients with normal renal function
- Trial name
- NCT02923947
- Testing
- Osimertinib; AZD9291
- Where
- 11 sites in France, South Korea and 1 more
- Volunteers
- 16 people
- Sponsor
- AstraZeneca
Arthroplasty, Replacement, Thromboembolism
Pradaxa (Dabigatran Etexilate) 150 mg/q.d. in Patients With Moderate Renal Impairment After Hip or Knee Replacement Surgery
An observational cohort study on safety and efficacy to generate additional data on the benefit/risk profile of the 150 mg dose of Pradaxa in patients with renal impairment
- Trial name
- NCT00847301
- Where
- 53 sites in Austria, France and 5 more
- Volunteers
- 472 people
- Sponsor
- Boehringer Ingelheim
Coronary Artery Disease, Renal Impairment
Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Coronary Angiography
The main purpose of this study is to evaluate and compare the effects on kidney function of two contrast media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney damage associated with the…
- Trial name
- NCT00209430
- Testing
- Iodixanol 320 mgI/mL
- Where
- Sweden
- Volunteers
- 408 people
- Sponsor
- GE Healthcare
Healthy Volunteers, Patients
To Compare the Pharmacokinetics of a Single Oral Dose of TC-5214 in Subjects With Renal Impairment and With Subjects With Normal Renal Function
The purpose of this study is to compare the absorption and distribution of a single oral dose of TC-5214 in subjects with renal impairment and with subjects with normal renal function.
- Conditions
- Healthy Volunteers, Patients, Pharmacokinetics, Renal Impairment
- Trial name
- NCT01240967
- Testing
- TC-5214
- Where
- 2 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Acute Kidney Failure, Chronic Kidney Diseases
Enhancing Fluid Transfer Through the Skin, by Increased Sweat Rate, on Hemodialysis Patients
To demonstrate safety and performance of AquaPass System for improving fluid balance in hemo-dialysis patients, by increasing fluid loss via the skin.
- Trial name
- NCT06358365
- Testing
- The AquaPass System
- Where
- Israel
- Volunteers
- 5 people
- Sponsor
- AquaPass Medical Ltd.
Cardiovascular Disease, Chronic Kidney Failure
Effect of HCO1100 on Cardiovascular Function
The purpose of this study is to determine whether high porous membranes are effective in the treatment of cardiovascular events in chronic dialysis patients.
- Trial name
- HicoCARD (NCT01363921)
- Testing
- HCO 1100
- Where
- Germany
- Volunteers
- 10 people
- Sponsor
- Vantive Health LLC
Acute Kidney Injury
Study to Prevent Acute Kidney Injury After Cardiac Surgery Involving Cardiopulmonary Bypass
The objective of the study is to assess the safety and efficacy of ANG-3777 in preventing AKI compared to placebo when administered to patients at risk for developing acute kidney injury (AKI) following cardiac surgical…
- Trial name
- NCT02771509
- Testing
- ANG-3777
- Where
- 40 sites in United States, Brazil and 2 more
- Volunteers
- 275 people
- Sponsor
- Angion Biomedica Corp
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