Clinical trials: Major Complications
Fabry Disease, Chronic Kidney Disease, Stage IV (Severe)
Severe Renal Disease Study in Fabry Patients Treated With Fabrazyme
This study was designed to determine appropriate treatment with Fabrazyme at a biweekly dose of either 1 mg/kg or 3 mg/kg in a population of patients with severe renal disease burden.
- Trial name
- NCT00837824
- Testing
- Fabrazyme (agalsidase beta)
- Where
- 9 sites in United States
- Volunteers
- 20 people
- Sponsor
- Genzyme, a Sanofi Company
Ovarian Neoplasms, Platinum Sensitive Ovarian Cancer
A Maintenance Study With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of niraparib as maintenance in platinum sensitive ovarian cancer patients who have either gBRCAmut or a tumor with high-grade serous histology and…
- Trial name
- NCT01847274
- Testing
- Active comparator: Niraparib
- Where
- 112 sites in United States, Austria and 13 more
- Volunteers
- 596 people
- Sponsor
- Tesaro, Inc.
Renal Insufficiency, Chronic
Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Dabigatran Etexilate in Patients With Stable Severe Renal Disease.
The study to be conducted is a prospective, open label trial. It is designed to evaluate the pharmacokinetic/pharmacodynamic and coagulation parameters and safety of dabigatran etexilate in patients with chronic kidney disease.
- Trial name
- NCT01711853
- Testing
- Dabigatran Etexilate
- Where
- Netherlands
- Volunteers
- 19 people
- Sponsor
- Boehringer Ingelheim
Endometriosis
A Study to Evaluate Safety and Efficacy of Elagolix in Participants With Endometriosis With Associated Moderate to Severe Pain
This is a Phase 3, dose-escalation study designed to evaluate the safety and efficacy of both elagolix alone and elagolix plus estradiol/norethindrone acetate (E2/NETA) over 24 months in the management of endometriosis with…
- Trial name
- NCT03343067
- Testing
- elagolix, estradiol/norethindrone acetate (E2/NETA)
- Where
- 37 sites in United States
- Volunteers
- 11 people
- Sponsor
- AbbVie
Healthy, Renal Impairment
A Clinical Study of Enlicitide in Participants With Severe Renal Impairment (MK-0616-032)
Researchers have designed a new study medicine called enlicitide decanoate as a new way to lower the amount of low-density lipoprotein cholesterol (LDL-C) in a person's blood.
- Trial name
- NCT06643377
- Testing
- Enlicitide
- Where
- 5 sites in United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Diabetes Mellitus, Diabetes Mellitus Complications
Safety and Efficacy of Relamorelin Administered to Participants With Vomiting Symptoms and Moderate to Severe Diabetic Gastroparesis
The purpose of this study is to evaluate the effects of multiple dose regimens of relamorelin on vomiting episodes, gastric emptying and gastroparesis symptoms in participants with Type 1 and Type 2 diabetes mellitus and…
- Conditions
- Diabetes Mellitus, Diabetes Mellitus Complications, Gastroparesis
- Trial name
- NCT02357420
- Testing
- Relamorelin
- Where
- 98 sites in United States, Belgium and 5 more
- Volunteers
- 393 people
- Sponsor
- Allergan
Cervical Dysplasia, Cervical High Grade Squamous Intraepithelial Lesion
REVEAL 1 (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL)
HPV-301 is a prospective, randomized, double-blind, placebo controlled Phase 3 study to determine the efficacy, safety, and tolerability of VGX-3100 administered by intramuscular (IM) injection followed by electroporation (EP)…
- Conditions
- Cervical Dysplasia, Cervical High Grade Squamous Intraepithelial Lesion, HSIL
- Trial name
- REVEAL 1 (NCT03185013)
- Testing
- VGX-3100, Electroporation (EP)
- Where
- 60 sites in United States, Argentina and 17 more
- Volunteers
- 201 people
- Sponsor
- Inovio Pharmaceuticals
Endometriosis
A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Participants With Moderate to Severe Endometriosis-Associated Pain
The objective of this study is to evaluate safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in adult premenopausal female participants including the safety and efficacy of…
- Trial name
- NCT03213457
- Testing
- Estradiol/Norethindrone Acetate, Elagolix
- Where
- 197 sites in United States, Canada and 1 more
- Volunteers
- 681 people
- Sponsor
- AbbVie
Diabetic Neuropathies, Depressive Disorder, Major
Duloxetine in Patients With Diabetic in Peripheral Neuropathic Pain With or Without Co-morbid Major Depressive Disorder
The primary objective is to evaluate, separately in diabetic polyneuropathic pain (DPNP) patients with and without co-morbid major depressive disorder (MDD), whether duloxetine given as 60 mg to 120 mg once daily (QD) leads to a…
- Trial name
- NCT00844194
- Testing
- Duloxetine 60 mg QD, Duloxetine 30 mg QD, Duloxetine 90 mg QD
- Where
- 25 sites in Germany
- Volunteers
- 108 people
- Sponsor
- Boehringer Ingelheim
Respiratory Syncytial Virus Infection, Premature Birth
Palivizumab for Prevention of Severe Respiratory Syncytial Virus Infection in Russian Children
100 Russian children of 2 years of age and less in high-risk populations (preterm, and/or with heart and lung problems) will receive palivizumab (Synagis) 15 mg/kg intramuscularly as prophylaxis to severe respiratory syncytial…
- Conditions
- Respiratory Syncytial Virus Infection, Premature Birth, Bronchopulmonary Dysplasia, Congenital Heart Disease
- Trial name
- NCT01006629
- Testing
- palivizumab
- Where
- 19 sites in Russia
- Volunteers
- 100 people
- Sponsor
- Abbott
Neoplasms, Ovarian
A Study of MORAb-202 Versus Investigator's Choice Chemotherapy in Female Participants With Platinum-resistant High-grade Serous (HGS) Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
The purpose of the study is to assess the safety, tolerability, and efficacy of farletuzumab ecteribulin (MORAb-202) and compare it to Investigator's choice (IC) chemotherapy in female participants with platinum-resistant HGS…
- Trial name
- NCT05613088
- Testing
- MORAb-202, Paclitaxel, Pegylated Liposomal Doxorubicin (PLD)
- Where
- 50 sites in United States, Australia and 7 more
- Volunteers
- 106 people
- Sponsor
- Bristol-Myers Squibb
Endometriosis
Global Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Women With Moderate to Severe Endometriosis-associated Pain
A randomized study evaluating the continued safety and efficacy of elagolix in the management of moderate to severe endometriosis associated pain in adult pre-menopausal women who completed 6 months treatment in pivotal Study…
- Trial name
- NCT02143713
- Testing
- Elagolix
- Volunteers
- 496 people
- Sponsor
- AbbVie
Uremic Pruritus
CR845-CLIN3105: A Study to Evaluate the Safety and Effectiveness of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus
This is a multicenter, open-label study to evaluate the safety and effectiveness of intravenous (IV) CR845 at a dose of 0.5 mcg/kg administered after each dialysis session. The study includes an up to 12-week Treatment Period.
- Trial name
- NCT03998163
- Testing
- CR845 0.5 mcg/kg
- Where
- 47 sites in United States, Czechia and 2 more
- Volunteers
- 222 people
- Sponsor
- Cara Therapeutics, Inc.
Renal Insufficiency, Renal Impairment
Pharmacokinetics of Sugammadex (MK-8616) in Participants With Moderate and Severe Renal Insufficiency (MK-8616-105)
The purpose of this study is to evaluate the plasma pharmacokinetics of a single 4 mg/kg intravenous (IV) dose of sugammadex in participants with moderate and severe renal insufficiency compared to that in participants with…
- Trial name
- NCT02011490
- Testing
- sugammadex
- Where
- United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Renal Insufficiency
Afatinib in Subjects With Kidney Dysfunction
The primary objective of the current study is to investigate the influence of moderate to severe renal impairment on the pharmacokinetics and safety of a single dose afatinib in comparison to a control group with normal renal…
- Trial name
- NCT02096718
- Testing
- Afatinib healthy, Afatinib severe renally impaired, Afatinib moderate renally impaired
- Where
- Germany
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Known or Suspected Focal Liver Lesions, Severe Renal Impairment
Safety and Diagnostic Efficacy of Mangoral in Participants With Focal Liver Lesions and Reduced Kidney Function
The overall objective of this study is to evaluate the safety and diagnostic efficacy of Mangoral in liver MRI in participants with known or suspected focal liver lesions and severe renal impairment.
- Trial name
- SPARKLE (NCT04119843)
- Testing
- Mangoral
- Where
- 60 sites in United States, Argentina and 8 more
- Volunteers
- 87 people
- Sponsor
- Ascelia Pharma AB
Chronic Kidney Disease Associated Moderate to Severe Pruritus
To Evaluate the Efficacy and Safety of Nemolizumab for 12 Weeks in Participants With Chronic Kidney Disease With Associated Moderate to Severe Pruritus
The purpose of this study was to evaluate the efficacy of nemolizumab compared to placebo at reducing the intensity of pruritus after a 12-week treatment period in adult hemodialysis participants with moderate to severe pruritus.
- Trial name
- NIKAIA 1 (NCT05075408)
- Testing
- Nemolizumab
- Where
- 64 sites in United States, Hungary and 2 more
- Volunteers
- 258 people
- Sponsor
- Galderma R&D
Pain
Analgesic Effect of Different Combinations of Dexketoprofen Trometamol With Tramadol Hydrochloride in a Model of Moderate to Severe Pain
The purpose of this study is to evaluate the analgesic efficacy of Dexketoprofen Trometamol and Tramadol Hydrochloride given in combinations and the analgesic efficacy of each single component in comparison to placebo on moderate…
- Trial name
- DEX-TRA 02 (NCT01307020)
- Testing
- Dexketoprofen Trometamol, Tramadol Hydrochloride, Ibuprofen
- Where
- 16 sites in Germany, Hungary and 4 more
- Volunteers
- 745 people
- Sponsor
- Menarini Group
Pain
Study of Buprenorphine Sublingual Spray for the Treatment of Moderate to Severe Pain
The primary objective of this trial is to evaluate analgesic efficacy of Buprenorphine Sublingual (under the tongue) Spray compared with placebo in participants with postoperative pain after bunionectomy.
- Trial name
- NCT02634788
- Testing
- Buprenorphine
- Where
- 4 sites in United States
- Volunteers
- 322 people
- Sponsor
- INSYS Therapeutics Inc
Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic
A Study of Pevonedistat in People With Blood Cancers or Solid Tumors With Kidney or Liver Problems
Pevonedistat is a medicine to treat people with blood cancers or solid tumors. The main aim of the study is to learn about the levels of pevonedistat in the blood of participants with blood cancers or solid tumors, who also have…
- Conditions
- Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute, Renal Insufficiency
- Trial name
- NCT03814005
- Testing
- Azacitidine, Pevonedistat
- Where
- 8 sites in United States, Spain
- Volunteers
- 17 people
- Sponsor
- Takeda