Clinical trials: Menopausal Hormone Therapy
Chronic Renal Anemia
A Study to Assess All-Cause Mortality and Cardiovascular Morbidity in Participants With Chronic Kidney Disease (CKD) on Dialysis and Those Not on Renal Replacement Therapy Receiving Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) or Reference Erythropoietin Stimulating Agents (ESAs)
This 2 arm safety study will compare the outcome with respect to a composite endpoint of all-cause mortality and non-fatal cardiovascular events (myocardial infarction, stroke) in CKD participants either on dialysis or not…
- Trial name
- NCT00773513
- Testing
- Darbepoetin Alfa, Epoetin Alfa, Epoetin Beta
- Where
- 196 sites in Argentina, Australia and 25 more
- Volunteers
- 2,825 people
- Sponsor
- Hoffmann-La Roche
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
Adult Growth Hormone Deficiency (AGHD)
Open-label Extension Study to Evaluate the Safety of Long-term Twice-monthly Administration of Somavaratan in Adult Growth Hormone Deficiency (AGHD)
Open-label extension study to evaluate the safety of long-term twice-monthly administration of somavaratan in adults with Growth Hormone Deficiency (GHD).
- Trial name
- NCT02719990
- Testing
- somavaratan
- Volunteers
- 36 people
- Sponsor
- Versartis Inc.
Hormone Replacement Therapy
Efficacy of Gynodian® Depot in Women With Impaired Well-being
The typical menopausal symptoms that are associated with a variety of physical and psychological changes (e.g. nervousness, anxiety, and depression) and also with impaired sexual interest and enjoyment are caused by a lack of…
- Trial name
- NCT00463450
- Testing
- Gynodian® Depot (BAY86-5032), BAY86-4980
- Volunteers
- 140 people
- Sponsor
- Bayer
AKI - Acute Kidney Injury, Acute Renal Failure
A Post-Market Clinical Performance and Safety Evaluation of GamCath HighFlow Dolphin Protect Catheter
The goal of this retrospective chart review is to obtain clinical safety and performance data for the GamCath HighFlow Dolphin Protect Catheter in patients with acute kidney injury, acute renal failure, or chronic kidney disease.
- Conditions
- AKI - Acute Kidney Injury, Acute Renal Failure, CKD, ESRD
- Trial name
- NCT05888376
- Testing
- Vascular access catheter to support dialysis or CRRT
- Where
- 2 sites in Poland
- Volunteers
- 76 people
- Sponsor
- Vantive Health LLC
Lysosomal Acid Lipase Deficiency
Acid Lipase Replacement Investigating Safety and Efficacy (ARISE) in Participants With Lysosomal Acid Lipase Deficiency
This Phase 3 study evaluated the efficacy and safety of 1 milligram/kilogram (mg/kg) intravenous (IV) infusions of SBC-102 (sebelipase alfa) administered every other week (qow) in participants with late onset lysosomal acid…
- Trial name
- ARISE (NCT01757184)
- Testing
- Sebelipase Alfa
- Where
- 40 sites in United States, Argentina and 13 more
- Volunteers
- 66 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Heart Failure, Congestive, Dilated Cardiomyopathy
Efficacy and Safety Study of Genetically Targeted Enzyme Replacement Therapy for Advanced Heart Failure
The study is divided into 2 parts. In the first part, the safety of the gene transfer agent MYDICAR® will be evaluated. In the second part, the ability of MYDICAR® to improve heart function will be studied.
- Trial name
- CUPID (NCT00454818)
- Testing
- MYDICAR Phase 1 (Open-label, Serial Dose-Escalation Study)
- Where
- 22 sites in United States
- Volunteers
- 51 people
- Sponsor
- Celladon Corporation
Renal Insufficiency / Therapy
PD Catheter Data Collection
Peritoneal Dialysis (PD) is a Renal Replacement Therapy for patients with renal insufficiency that has been used more frequently in recent years.
- Trial name
- Catheter (NCT07156123)
- Where
- 2 sites in Germany
- Volunteers
- 300 people
- Sponsor
- Fresenius Medical Care Deutschland GmbH
Hypoinsulinemia
Transdermally Delivered Human Insulin Product
An Early Feasibility Study of a device formulation to deliver human insulin across intact skin
- Trial name
- NCT03544996
- Testing
- TD Insulin
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Transdermal Delivery Solutions Corp
Renal Failure, End Stage Renal Disease
Comparison of Efficacy and Tolerability of APD Treatment With Different PD Cyclers
The study has been designed in order to investigate the performance and safety of the new Silencia PD cycler including the Silencia tubing system in comparison to the PD-Night and Homechoice PD cycler which are both…
- Trial name
- NCT04749680
- Testing
- PD cycler Silencia
- Where
- 4 sites in Chile
- Volunteers
- 16 people
- Sponsor
- Fresenius Medical Care Deutschland GmbH
Primary Immunodeficiency
An Open-label, Multicenter Study to Assess the Pharmacokinetics (PK), Safety, and Tolerability of Subcutaneous IgPro20 in Immunoglobulin (IG) Treatment-naïve Participants With Primary Immunodeficiency (PID)
This is an open-label, multicenter, phase 4 study in IG treatment-naïve participants with PID, conducted in the United States (US), to assess the PK, safety, and tolerability of IgPro20.
- Trial name
- NCT07076446
- Testing
- IgPro
- Where
- 8 sites in United States
- Volunteers
- 8 people
- Sponsor
- CSL Behring
Severe Native Calcific Aortic Stenosis, Symptomatic Heart Disease Due to Severe Native Calcific Aortic Stenosis
Validation Of anatomY-specific Aortic Valve Implantation Guided by Software Using EncantoR
VOYAGER CE Clinical Study using the Encantor TAVI System.
- Trial name
- VOYAGER CE (NCT07696182)
- Testing
- Prospective, single-arm, multi-center study.
- Volunteers
- 150 people
- Sponsor
- Abbott Medical Devices
Gaucher Disease
An Open-Label, Dose Escalation Study to Evaluate the Safety and the Pharmacokinetics of Oral PRX-112
This is an open-label, dose escalation study to evaluate the safety of oral PRX-112 and pharmacokinetics of GCD in subjects with Gaucher disease naive to enzyme replacement therapy.
- Trial name
- NCT02107846
- Testing
- PRX-112
- Where
- Israel
- Volunteers
- 10 people
- Sponsor
- Protalix
Smoking Cessation
Provoked Craving Relief Study by NRT
This study is designed to assess the ability of the mint nicotine mouth strip to relieve provoked cigarette craving in light smokers compared to nicotine lozenge and nicotine gum.
- Trial name
- NRT (NCT01476202)
- Testing
- nicotine
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Regional Citrate Anticoagulation (RCA), Continuous Renal Replacement Therapy (CRRT)
Safety Evaluation of Prismocitrate 18 in Patients Receiving CRRT
Prismocitrate 18 is a continuous renal replacement therapy (CRRT) solution to be used as a renal replacement solution and as an anticoagulant to prevent blood clotting in the extracorporeal circuit.
- Conditions
- Regional Citrate Anticoagulation (RCA), Continuous Renal Replacement Therapy (CRRT), Acute Kidney Injury (AKI)
- Trial name
- NCT05399537
- Testing
- Prismocitrate 18, PrisMax System Version 3.x with calcium line accessory
- Where
- 14 sites in United States
- Volunteers
- 40 people
- Sponsor
- Vantive Health LLC
Mucopolysaccharidosis I
Immune Tolerance Study With Aldurazyme® (Laronidase)
The purpose of this study is to see if treatment with an antigen-specific immunosuppressive can decrease or stop an antibody response to laronidase (Aldurazyme®) during enzyme replacement therapy with laronidase in severe…
- Trial name
- NCT00741338
- Testing
- Laronidase, Cyclosporine A (CsA), Azathioprine (Aza)
- Where
- 2 sites in Brazil, Russia
- Volunteers
- 7 people
- Sponsor
- Genzyme, a Sanofi Company
Anemia
A Study of Mircera in Anemic Patients With Chronic Kidney Disease Not Yet on Dialysis.
This study will evaluate the efficacy and safety of different subcutaneous starting doses and dosing frequencies of Mircera in anemic patients with chronic kidney disease not yet on dialysis.
- Trial name
- NCT00048048
- Testing
- methoxy polyethylene glycol-epoetin beta [Mircera]
- Where
- 15 sites in United States, Canada and 3 more
- Volunteers
- 65 people
- Sponsor
- Hoffmann-La Roche
Acute Kidney Injury, Renal Failure
Analysis of Continuous Kidney Replacement Therapy (CKRT) Treatments With multiFlux Hemofilters Using Regional Citrate Anticoagulation (RCA) or Systemic Heparin Anticoagulation
The goal of this observational study is to assess the performance of the multiFlux hemofilterwith regional or systemic anticoagulation during CKRT treatments.
- Trial name
- RCA-Flux (NCT07679568)
- Testing
- multiFlux 160 hemofilter with regional heparin anticoagulation, multiFlux 160 hemofilter with RCA with regional citrate anticoagulation, multiFlux 130 hemofilter with regional heparin anticoagulation
- Where
- Germany
- Volunteers
- 62 people
- Sponsor
- Fresenius Medical Care Deutschland GmbH
Brain Injuries, Growth Hormone Deficiency
Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury
To establish the effects of genotropin replacement on cognitive function in patients with severe growth hormone deficiency after traumatic brain injury.
- Trial name
- NCT00555009
- Testing
- Genotropin
- Where
- 9 sites in France, Italy and 4 more
- Volunteers
- 10 people
- Sponsor
- Pfizer
Gaucher Disease Type 1
Clinical Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Miglustat in Patients With Stable Type 1 Gaucher Disease
Although miglustat has been approved as a treatment for mild to moderate type 1 Gaucher disease in patients who are unsuitable for enzyme replacement therapy (ERT), more data are required to establish the long term efficacy…
- Trial name
- NCT00319046
- Testing
- Miglustat
- Volunteers
- 42 people
- Sponsor
- Actelion