Clinical trials: Chronic End Stage Renal Failure
Chronic Renal Failure Requiring Hemodialysis
A Phase 3, Long-Term Safety Study of Subcutaneous Epoetin Hospira in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment. AiME -Anemia Management With Epoetin
To determine the long term safety in treatment-emergent adverse events (TEAEs) of SC administration of Epoetin Hospira for maintenance of target hemoglobin (Hgb) levels in patients treated for anemia associated with chronic renal…
- Trial name
- AiME - 04 (NCT01628120)
- Testing
- Epoetin Hospira
- Where
- 115 sites in United States
- Volunteers
- 170 people
- Sponsor
- Pfizer
End Stage Renal Disease
Efficacy and Safety of XyloCore Peritoneal Dialysis Solution.
Randomized, controlled, parallel groups, open-label, blinded end-point assessment, multicenter study, comparing the effects of a low glucose peritoneal dialysis solution, XyloCore, to glucose solutions (Physioneal, Fixioneal…
- Trial name
- ELIXIR (NCT03994471)
- Testing
- XyloCore Low Strenght, XyloCore Medium Strenght, XyloCore High Strenght, 1.36%, 1.5%, 2.27%, 2.5%, 3.86%, 2.25% Glucose PD Solution
- Where
- 41 sites in Denmark, Germany and 4 more
- Volunteers
- 170 people
- Sponsor
- Iperboreal Pharma Srl
End Stage Renal Disease
Effect of Lanthanum Carbonate in Patients Previously Treated With Calcium-based Phosphate Binder Therapy
To assess the percentage of patients on lanthanum carbonate, that achieve Kidney Disease Outcome Quality Initiative (KDOQI) guideline suggested values for serum phosphorous in patients previously treated with calcium-based…
- Trial name
- NCT01130831
- Testing
- Lanthanum carbonate
- Where
- 31 sites in Germany
- Volunteers
- 66 people
- Sponsor
- Shire
Chronic Kidney Failure, Secondary Hyperparathyroidism
Follow-up Patients With End Stage Renal Disease Receiving Zemplar to Prevent and Treat Secondary Hyperparathyroidism
The aim of this post-marketing observational study is to obtain further data on the long term use, safety and efficacy of Zemplar as it is prescribed in the normal clinical setting and according to the approved Summary of Product…
- Trial name
- NCT01081665
- Where
- 19 sites in Greece
- Volunteers
- 237 people
- Sponsor
- Abbott
End Stage Renal Disease, AV Fistula
Percutaneous Less Invasive AV Fistula for Vascular Access in ESRD
A prospective single-arm well-controlled study to evaluate the safety and effectiveness of a less invasive means of establishing vascular access to facilitate dialysis in patients with end stage renal disease.
- Conditions
- End Stage Renal Disease, AV Fistula, Fistula, End Stage Kidney Disease
- Trial name
- NCT02363972
- Testing
- Ellipsys Vascular Access Catheter
- Where
- 5 sites in United States
- Volunteers
- 103 people
- Sponsor
- Medtronic Endovascular
Renal Insufficiency, Kidney Diseases
Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of INCB054707 in Participants With Normal and Impaired Renal Function and Participants on Hemodialysis
This is a multi-center, open-label, parallel-group study to evaluate oral doses of INCB054707 in participants with varying levels of renal function or impairment.
- Trial name
- NCT05624723
- Testing
- INCB054707
- Where
- 2 sites in United States, Germany
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Incyte Corporation
Anemia, Chronic Kidney Disease
Safety, PD & PK of Multiple Doses of Peginesatide for Anemia in Chronic Kidney Disease Patients
The purpose of this study was to evaluate the safety, pharmacodynamics (PD), and pharmacokinetics (PK) of multiple subcutaneous injections of peginesatide in participants with chronic kidney disease (CKD) not on dialysis who had…
- Conditions
- Anemia, Chronic Kidney Disease, Chronic Renal Failure
- Trial name
- NCT00228436
- Testing
- peginesatide
- Where
- 13 sites in Poland, United Kingdom
- Volunteers
- 139 people
- Sponsor
- Affymax
End Stage Renal Disease
Confirmatory Study to Assess the V Needle in End-Stage Renal Disease Patients During In-Clinic Hemodialysis
This study is a prospective, multi-center, single-arm study with subjects acting as their own control designed to confirm the safety, performance, and usability of the V Needle, a new safety needle for use during in-clinic…
- Trial name
- Clinic-SAVER (NCT05493423)
- Testing
- V Needle AV Fistula Set
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Hemotek Medical Inc
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
End-stage Renal Disease, Kidney Failure, Chronic
Safety and Efficacy of a Vascular Prosthesis for Hemodialysis Access in Patients With End-Stage Renal Disease
The purpose of this study is to assess the safety and efficacy of a novel, tissue-engineered vascular prosthesis, the Human Acellular Vascular Graft, HAVG.
- Trial name
- NCT01840956
- Testing
- HAVG
- Where
- 3 sites in United States
- Volunteers
- 20 people
- Sponsor
- Humacyte, Inc.
End Stage Renal Disease
Evaluation of Anti-platelet Factor 4/Heparin Antibodies in Hemodialysis Patients
To characterize the GORE® Hybrid Vascular Graft as compared to non-heparin bonded synthetic vascular grafts in terms of the prevalence and persistence of anti-platelet factor 4 / heparin antibodies (anti-PF4 / H antibodies).
- Trial name
- NCT02165761
- Testing
- GORE® Hybrid Vascular Graft, Non-heparin bonded synthetic graft
- Where
- 4 sites in United States
- Volunteers
- 42 people
- Sponsor
- W.L.Gore & Associates
Chronic Kidney Disease
Observational Study of Kibow Biotics in Chronic Kidney Failure Patients on Dialysis
A specifically formulated probiotic product comprised of defined and tested microbial strains may afford renoprotection in what has been generally called "Enteric DialysisTM".
- Trial name
- NCT01450709
- Testing
- Kibow Biotics
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Kibow Pharma
End Stage Renal Disease
Evaluation of STARgraft AV for Hemodialysis Access
This study is a First-in-Human, single site, prospective, randomized, controlled evaluation of the safety and effectiveness of the Healionics STARgraft AV hemodialysis access graft.
- Trial name
- NCT03916731
- Testing
- STARgraft AV, ePTFE AV graft (control)
- Where
- Paraguay
- Volunteers
- 55 people
- Sponsor
- Healionics Corporation
End-Stage Renal Disease (ESRD), End-Stage Kidney Disease (ESKD)
Single Dose Study of MK-2060 to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Older Japanese Participants on Dialysis (MK-2060-012)
The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of MK-2060 after a single dose intravenous (IV) administration in Japanese older participants with end stage renal…
- Conditions
- End-Stage Renal Disease (ESRD), End-Stage Kidney Disease (ESKD), Kidney Failure, Chronic
- Trial name
- NCT05769595
- Testing
- MK-2060
- Where
- 12 sites in Japan
- Volunteers
- 17 people
- Sponsor
- Merck Sharp & Dohme LLC
End-stage Kidney Disease, End-stage Renal Disease
The Optiflow Patency and Maturation Study
The objective of this study is to assess the performance and safety of the Optiflow Anastomotic Connector (Optiflow) when used to facilitate the creation of autogenous arteriovenous fistula (AVF) anastomoses.
- Trial name
- OPEN (NCT01921933)
- Testing
- Optiflow
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- Bioconnect Systems, Inc
End Stage Kidney Disease (ESRD)
Effect of the Amplifi™ Vein Dilation System on Outflow Vein Dilation and AV Fistula Maturation (AMPLIFI-1)
The AMPLIFI-1 Study is a prospective, multicenter pivotal clinical trial designed to evaluate the safety and effectiveness of the Amplifi™ Vein Dilation System in patients requiring distal arteriovenous fistula (AVF) creation for…
- Trial name
- AMPLIFI-1 (NCT07211035)
- Testing
- The Amplifi System is a temporary extracorporeal blood pump designed to deliver controlled flow through a peripheral vein for 24-72 hours prior to AVF creation., Standard of Care (AVF creation)
- Where
- 2 sites in United States
- Volunteers
- 160 people
- Sponsor
- Amplifi Vascular, Inc.
Chronic Renal Failure
Use Of Fragmin In Hemodialysis
The study will determine if the Fragmin dose can be adjusted to suit the clinical needs of patients during dialysis.
- Trial name
- NCT01879618
- Testing
- Fragmin
- Where
- 19 sites in Canada
- Volunteers
- 152 people
- Sponsor
- Pfizer
Renal Insufficiency, Kidney Disease
A Study to Evaluate the Pharmacokinetics Of Sativex® in Subjects With Severe Renal Impairment or End Stage Renal Disease, Compared to Matched Subjects With Normal Renal Function.
The study aims to determine the pharmacokinetic (PK) profile of a single oromucosal dose of Sativex® (i.e. how the body absorbs, distributes, metabolises and excretes the drug) when subjects have severe renal impairment or end…
- Trial name
- NCT02325024
- Testing
- Sativex
- Volunteers
- healthy volunteers welcome
- Sponsor
- GW Pharmaceuticals Ltd
End Stage Renal Disease
Comparison of the Clinical Performance of 3 THERANOVA 400 Dialyzer Prototypes With a High-Flux Dialyzer in Hemodialysis Mode
The study investigates the performance of a new dialyzer (Theranova 400) containing a membrane with increased pore sizes. The performance will be determined by the removal of middle molecules (with different molecular size) from…
- Trial name
- NCT02377570
- Testing
- THERANOVA 400 dialyzer prototype AA, THERANOVA 400 dialyzer prototype BB, THERNOVA 400 dialyzer prototype CC
- Where
- Austria
- Volunteers
- 20 people
- Sponsor
- Vantive Health LLC
Chronic Kidney Disease Stage 3B, Chronic Kidney Disease stage4
Low-Protein Diet With Low-Protein Foods Versus a LPD Without LP Foods in Patients With Chronic Kidney Disease (CKD)
The KDOQI 2020 - Clinical practice guideline for nutrition in chronic kidney disease (CKD) -recommends protein restriction to reduce the risk of end-stage renal disease/death and improve quality of life, a low protein diet…
- Conditions
- Chronic Kidney Disease Stage 3B, Chronic Kidney Disease stage4, Chronic Kidney Disease Stage 5, Chronic Kidney Disease Stage 3A
- Trial name
- NCT05489120
- Testing
- Consumption of FLAVIS
- Where
- 18 sites in France
- Volunteers
- 210 people
- Sponsor
- Dr. Schär AG / SPA