Clinical trials: Kidney Diseases
End Stage Renal Disease on Hemodialysis (Diagnosis)
HEPLISAV-B® in Adults With End-Stage Renal Disease (ESRD) Undergoing Hemodialysis
This is an open-label, single arm study design to evaluate HEPLISAV-B® in adults with ESRD who are initiating or undergoing hemodialysis.
- Trial name
- NCT03934736
- Testing
- HEPLISAV-B®
- Where
- 20 sites in United States
- Volunteers
- 119 people
- Sponsor
- Dynavax Technologies Corporation
Chronic Kidney Disease
Dialysis Clinical Outcomes Revisited (DCOR) Trial
This is a randomized, open-label, parallel-design study to be conducted at 75 centers within the United States. The study will be described to hemodialysis patients.
- Trial name
- NCT00324571
- Testing
- Sevelamer hydrochloride, Calcium-based phosphate binder
- Where
- 73 sites in United States, Puerto Rico
- Volunteers
- 2,000 people
- Sponsor
- Genzyme, a Sanofi Company
Kidney Disease
A Phase IIb, Multicenter, Open-Label, Prospective Study of Bremelanotide in Diabetic Kidney Disease
This is a prospective, open-label trial to assess the efficacy of melanocortin receptor agonist bremelanotide (BMT) when administered with RAAS inhibition therapy after six months in subjects with Type II diabetic nephropathy.
- Trial name
- BREAKOUT (NCT05709444)
- Testing
- Bremelanotide, RAAS inhibition therapy
- Where
- 9 sites in United States
- Volunteers
- 16 people
- Sponsor
- Palatin Technologies, Inc
Primary Hyperoxaluria
Expanded Access Protocol to Provide Lumasiran to Patients With Primary Hyperoxaluria Type 1
The purpose of this study is to provide expanded access to lumasiran for adults and pediatric patients with Primary Hyperoxaluria Type 1 (PH1),
- Trial name
- NCT04125472
- Testing
- Lumasiran
- Sponsor
- Alnylam Pharmaceuticals
Renal Impairment
A Phase l Study to Evaluate the Pharmacokinetics and Safety Pasireotide in Subjects With Varying Degrees of Renal Impairment Compared to Healthy Volunteers
The purpose of this study is to assess the effect of renal impairment on the pharmacokinetics (PK) of pasireotide,the PK of pasireotide in subjects with different degrees of renal impairment.
- Trial name
- NCT01578928
- Testing
- SOM230
- Where
- 2 sites in Germany, South Africa
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Atypical Hemolytic Uremic Syndrome(aHUS)
A Prospective, Non-interventional, Observational Study of Presentation, Treatment Patterns and Outcomes in Atypical Hemolytic Uremic Syndrome Patients
This is a China, non-interventional, observational study and will follow the Good Phar-macoepidemiology Practices guidelines. This study will enrol paediatric and adult patients diagnosed with aHUS who will be treated according…
- Trial name
- NCT06099236
- Where
- 26 sites in China
- Volunteers
- 367 people
- Sponsor
- AstraZeneca
Chronic Kidney Disease
Effect of Low Frequency Ultrasound on Kidney Function
The purpose of this study is to find out what effect, if any, Low Frequency Therapeutic Ultrasound (LOTUS) has on kidney function in patients with chronic kidney disease.
- Trial name
- NCT02026544
- Testing
- Low Frequency Therapeutic Ultrasound
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Sonogenix
Primary Hyperoxaluria
Phase 2/3 Oxabact Study
The purpose of this study is to determine if Oxalobacter formigenes is effective at lowering urinary oxalate levels in patients with primary hyperoxaluria.
- Trial name
- NCT01037231
- Testing
- Oxalobacter formigenes
- Where
- 3 sites in United States, Germany and 1 more
- Volunteers
- 36 people
- Sponsor
- OxThera
Pain, Neuropathic, Epilepsy
Cancer in Patients With Gabapentin (GPRD)
High doses of gabapentin are associated with pancreatic acinar cell tumors in rats, but there has been no post marketing pancreatic carcinogenicity signal with gabapentin as reported by spontaneous reports in AERS or in the…
- Conditions
- Pain, Neuropathic, Epilepsy, Renal Pelvis Cancer, Pancreatic Cancer
- Trial name
- NCT01236053
- Testing
- Gabapentin prescriptions
- Volunteers
- 2,323,608 people
- Sponsor
- GlaxoSmithKline
Renal Failure, Hemodialysis
GORE VIABAHN Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise AV Grafts in Hemodialysis
The objective of the study is to establish efficacy and safety of the GORE VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface when used to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the…
- Trial name
- REVISE (NCT00737672)
- Testing
- GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface, Percutaneous Transluminal Angioplasty
- Where
- 31 sites in United States
- Volunteers
- 293 people
- Sponsor
- W.L.Gore & Associates
Anemia Associated With Chronic Kidney Disease
Investigating the Efficacy, Safety and PK of Roxadustat (FG-4592) for Treatment of Anemia in Pediatric Patients With CKD
This open-labeled, multicenter study is designed to evaluate the efficacy, safety and PK/PD of roxadustat in ESA-naïve and ESA-treated pediatric patients with CKD Stages 3, 4, and 5, as well as end-stage renal disease (ESRD) who…
- Trial name
- NCT04621331
- Testing
- Roxadustat
- Where
- 4 sites in United States
- Sponsor
- Kyntra Bio
Gastrointestinal Cancer
Oxaliplatin With FOLFOX4 in Patients With Normal and Abnormal Renal Function
This trial is a phase II study in patients with advanced gastrointestinal (GI) malignancies who will be assigned to one of 4 cohorts (normal, mild, moderate and several renal dysfunction) based on their baseline measured…
- Trial name
- FOLFOX4 (NCT00094965)
- Testing
- Oxaliplatin (SR96669)
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- Sanofi
Carcinoma, Renal Cell
Nexavar Post-marketing Surveillance for RCC in Japan: Early Access Program
This study is an early access program of 'Nexavar post-marketing surveillance (PMS) for renal cell carcinoma (RCC) in Japan' which is a regulatory, local prospective and observational study for patients with unresectable or…
- Trial name
- NCT01412671
- Testing
- Sorafenib (Nexavar, BAY43-9006)
- Where
- Japan
- Volunteers
- 117 people
- Sponsor
- Bayer
Focal Segmental Glomerulosclerosis, Immunoglobulin A Nephropathy
Humanistic Burden of (FSGS) Focal Segmental Glomerulosclerosis and IgAN (Immunoglobulin A Nephropathy)
The aim of this observational study is to assess humanistic burden among adults and children/adolescents with FSGS and IgAN as well as the burden and impact for patient care-partners in six countries (United States [US], United…
- Trial name
- HONUS (NCT05200871)
- Where
- 6 sites in United States, Germany and 1 more
- Volunteers
- 487 people
- Sponsor
- Travere Therapeutics, Inc.
Chronic Kidney Disease, Chronic Renal Failure
A Phase 3 Study Comparing the Effects of Intravenous Epoetin Hospira and Epoetin Alfa [Epogen] (Amgen) in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment. AiME - Anemia Management With Epoetin
The purpose of this study is to demonstrate therapeutic equivalence of IV Epoetin Hospira compared to IV Epogen (Amgen), based on maintenance of Hb levels and study drug dose requirements in patients treated for anemia associated…
- Trial name
- AiME - 01 (NCT01473407)
- Testing
- Epoetin Hospira, Epogen (Amgen)
- Where
- 85 sites in United States, Puerto Rico
- Volunteers
- 612 people
- Sponsor
- Pfizer
Hemodialysis Chronic Kidney Disease Patients With Anemia
A Study of Intermittent Oral Dosing of ASP1517 in Hemodialysis Chronic Kidney Disease Patients With Anemia
The objective of this study is to evaluate the safety and efficacy of ASP1517 compared to darbepoetin alfa in hemodialysis chronic kidney disease patients with anemia.
- Trial name
- NCT02952092
- Testing
- roxadustat, Darbepoetin alfa
- Where
- 57 sites in Japan
- Volunteers
- 303 people
- Sponsor
- Astellas Pharma Inc
Advanced Solid Tumors Cancer
A Study Evaluating the Safety, Pharmacokinetics and Anti-Tumor Activity of ABBV-176 in Subjects With Advanced Solid Tumors Likely to Express Prolactin Receptor (PRLR)
This is an open-label, Phase I, dose-escalation study to determine the maximum tolerated dose (MTD) and the recommended phase two dose (RPTD), and to assess the safety, preliminary efficacy, and pharmacokinetic (PK) profile of…
- Trial name
- NCT03145909
- Testing
- ABBV-176
- Where
- 11 sites in United States, Australia and 2 more
- Volunteers
- 19 people
- Sponsor
- AbbVie
Hepatitis C, Chronic
A Study of Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) Combination Therapy in Participants With Chronic Hepatitis C (CHC) and Various Degrees of Renal Impairment
This study will evaluate the pharmacokinetics (area under the curve [AUC], maximum concentration [Cmax], and other parameters) and tolerability of peginterferon alfa-2a and ribavirin combination therapy following single and…
- Trial name
- NCT02864199
- Testing
- Peginterferon alfa-2a, Ribavirin
- Where
- 17 sites in United States, Brazil and 3 more
- Volunteers
- 63 people
- Sponsor
- Hoffmann-La Roche
End-stage Renal Disease
Clearum High Flux Hemodialyzer Used in Hemodialysis for Subjects With End-Stage Renal Disease
The study will be a prospective, interventional, non-randomized, single-center study in 20 ESRD patients on hemodialysis. The study will compare performance of the Clearum HS dialyzer to typical values obtained with other…
- Trial name
- NCT04395131
- Testing
- Clearum HF Hemodialyzer
- Where
- Germany
- Volunteers
- 20 people
- Sponsor
- Mozarc Medical US LLC
COPD
Drug-drug Interaction Study of CHF5993 With Cimetidine
The purpose of this study is to evaluate the pharmacokinetic interaction when CHF5993 (pressurized metered-dose inhaler (pMDI) is administered with Cimetidine (probe inhibitor of the organic cation transport in the kidneys), by…
- Trial name
- NCT02287272
- Testing
- CHF 5993 pMDI, Cimetidine plus CHF5993 pMDI
- Where
- Belgium
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
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