Clinical trials: Injection Complication
Nephrogenic Systemic Fibrosis, Renal Insufficiency
Evaluation of Nephrogenic Systemic Fibrosis (NSF) in Patients With Chronic Kidney Disease Following OptiMARK Injection
The objective of this study is to prospectively monitor the incidence of adverse drug reactions, specifically NSF during routine use of gadoversetamide in a large number of patients with moderate renal insufficiency (eGFR 30-59)…
- Trial name
- SHERLOC (NCT00811863)
- Where
- United States
- Sponsor
- Guerbet
Kidney Failure, Chronic, Renal Disease, End-Stage
Pharmacokinetics/Pharmacodynamics of Argatroban Injection in End-Stage Renal Disease Patients Undergoing Hemodialysis
The primary goals of this investigation are to provide guidance on how to dose Argatroban in patients undergoing hemodialysis and to assess the safety and tolerability of Argatroban in hemodialysis patients.
- Trial name
- NCT00035178
- Testing
- Argatroban
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Texas Biotechnology Corporation
Postoperative Pain
Study Evaluating the Safety, Efficacy and Pharmacokinetics of SYH9089 Injection in Patients Undergoing Abdominal Surgery.
This is a randomized, double-blind, active drug- and placebo-controlled, dose-escalation clinical study conducted in patients scheduled to undergo abdominal surgery.
- Trial name
- NCT07519109
- Testing
- SYH9089 injection, Ropivacaine hydrochloride, 0.9 % sodium chloride
- Where
- China
- Volunteers
- 60 people
- Sponsor
- CSPC Ouyi Pharmaceutical Co., Ltd.
Hepatorenal Syndrome
Safety and Pharmacokinetics of Ifetroban in Hepatorenal Syndrome Patients
A study of ifetroban in the treatment of hepatorenal syndrome (HRS) in hospitalized adult patients to assess the safety and pharmacokinetics of 3 days of intravenous ifetroban.
- Trial name
- NCT01436500
- Testing
- Ifetroban Injection
- Where
- 12 sites in United States, India
- Volunteers
- 55 people
- Sponsor
- Cumberland Pharmaceuticals
Postpartum Depression
A Study to Evaluate Efficacy and Safety of SAGE-547 in Participants With Severe Postpartum Depression (547-PPD-202B)
The purpose of this study was to determine if SAGE-547 Injection infused intravenously at up to 90 micrograms per kilogram per hour (μg/kg/h) for 60 hours reduces depressive symptoms in participants with severe postpartum…
- Trial name
- NCT02942004
- Testing
- SAGE-547 60 μg/kg/h, SAGE-547 90 μg/kg/h
- Where
- 32 sites in United States
- Volunteers
- 138 people
- Sponsor
- Supernus Pharmaceuticals, Inc.
Iron Deficiency Anemia, Chronic Kidney Disease
Iron Isomaltoside 1000 (Monofer®) in Non-Dialysis Dependent Chronic Kidney Disease and With Renal-Related Anaemia
The study is designed to determine the effects of an investigational drug Monofer in subjects with non-dialysis dependent chronic kidney disease (NDD-CKD) subjects and with iron deficiency anaemia (IDA).
- Trial name
- NCT01102413
- Testing
- Monofer, Iron Sulphate
- Where
- Denmark
- Volunteers
- 351 people
- Sponsor
- Pharmacosmos A/S
Non-muscle-invasive Bladder Cancer, NMIBC
A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in Bladder Cancer
The main objectives of this study are to determine the feasibility and safety of Belzupacap Sarotalocan (AU-011, bel-sar) treatment of bladder cancer utilizing focal injections with or without laser application.
- Conditions
- Non-muscle-invasive Bladder Cancer, NMIBC, Non-Muscle Invasive Bladder Carcinoma, Non-Muscle Invasive Bladder Neoplasms
- Trial name
- NCT05483868
- Testing
- AU-011, AU-011 in Combination with Medical Laser Adminstration, AU-011 in Combination with Medical Laser Administration
- Where
- 19 sites in United States, Australia
- Volunteers
- 55 people
- Sponsor
- Aura Biosciences
Postsurgical Pain
Study to Evaluate Safety/Efficacy of a Single Pre-Op Dose of AYX1 Injection to Treat Pain After Knee Replacement Surgery
The objectives of this study are to evaluate the safety and analgesic efficacy of a single preoperative intrathecal administration of AYX1 Injection at two dose/volume levels.
- Trial name
- NCT02081703
- Testing
- AYX1 Injection 660 mg / 6 mL, AYX1 Injection 1100 mg / 10 mL
- Where
- 2 sites in United States
- Volunteers
- 120 people
- Sponsor
- Adynxx, Inc.
Treatment Related Cancer, Ovarian Cancer
SY001 Targets Mesothelin in a Single-arm, Dose-increasing Setting in Subjects With Advanced Solid Tumors
Single-arm, dose-increasing setting study of CAR macrophages in Mesothelin overexpressing solid tumors.
- Trial name
- NCT06562647
- Testing
- SY001
- Where
- 2 sites in China
- Volunteers
- 2 people
- Sponsor
- Cell Origin Biotech (Hangzhou) Co., Ltd.
IgA Nephropathy (IgAN), Membranous Nephropathy
A Clinical Study Evaluating the Safety and Efficacy of GT719 Universal Cell Injection in the Treatment of Immune-mediated Kidney Diseases
This study is a single-arm, open-label, dose-escalation and dose-expansion clinical trial, divided into two phases: the first phase is the dose-escalation phase, and the second phase is the dose-expansion phase.
- Conditions
- IgA Nephropathy (IgAN), Membranous Nephropathy, ANCA-associated Vasculitis (AAV)/ANCA-associated Glomerulonephritis (AAGN), Refractory Podocytopathy
- Trial name
- NCT07389499
- Testing
- CD19-targeted iNKT Cell Injection
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Grit Biotechnology
Diabetes Mellitus, Diabetic Retinopathy
A Study to Evaluate THR-149 Treatment for Diabetic Macular Oedema
Part A of the study is conducted to select the THR-149 dose level. Part B of the study is conducted to assess the efficacy and safety of the selected dose level compared to aflibercept, up to Month 3.
- Conditions
- Diabetes Mellitus, Diabetic Retinopathy, Diabetic Macular Edema
- Trial name
- KALAHARI (NCT04527107)
- Testing
- THR-149 dose level 1, THR-149 dose level 2, THR-149 dose level 3
- Where
- 78 sites in United States, Czechia and 6 more
- Volunteers
- 135 people
- Sponsor
- Oxurion
Renal Impairments, IgA Nephropathy (IgAN)
A Study of RG002C0106 Injection in Adult Participants With Normal Renal Function and Mild-to-Moderate Renal Impairment
This is a Phase I trial designed to evaluate the impact of renal impairment on the efficacy and safety of the drug by comparing pharmacokinetic (PK) parameters and pharmacodynamic (PD) markers after a single subcutaneous…
- Trial name
- NCT07445906
- Testing
- RG002C0106
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Rigerna Therapeutics Co., Ltd.; Rigerna Therapeutics (Beijing) Co., Ltd.
Diabetic Nephropathy Type 2
Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cell Therapy in Diabetic Nephropathy Patients: A Clinical Trial
The goal of this clinical trial is to evaluate the safety and efficacy of a single intra-renal injection of allogeneic umbilical cord-derived mesenchymal stem cells (UC-MSCs) in adults with diabetic nephropathy aged 40 to 65…
- Trial name
- NCT07396155
- Testing
- Umbilical Cord Mesenchymal Stem Cells
- Where
- Indonesia
- Volunteers
- 10 people
- Sponsor
- PT. Prodia Stem Cell Indonesia
Diabetic Macular Edema
Study of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in Patients With Diabetic Macular Edema
The purpose of this study is to determine the efficacy of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) on the best corrected visual acuity (BCVA) assessed by the early treatment diabetic retinopathy study (ETDRS)…
- Trial name
- VISTA DME (NCT01363440)
- Testing
- Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321), Macular Laser Photocoagulation
- Where
- 51 sites in United States
- Volunteers
- 466 people
- Sponsor
- Regeneron Pharmaceuticals
Colorectal Cancer, Gastric Cancers
Study to Evaluate the Diagnostic Performance of GEH300079 (68Ga) Injection PET/CT for Detection of PC in Patients With Colorectal, Gastric, Ovarian, or Pancreatic Cancers (PERISCOPE)
This study is a Phase 2/3, prospective, multicenter, open-label, non-randomized clinical trial, in which GEH300079 (68Ga) PET/CT images will be acquired in patients with primary colorectal, gastric, ovarian, or Pancreatic Ductal…
- Conditions
- Colorectal Cancer, Gastric Cancers, Ovarian Cancers, Pancreatic Ductal Adenocarcinoma
- Trial name
- NCT07219238
- Testing
- GEH300079 (68Ga) Injection Positron-Emission Tomography (PET)/Computed Tomography (CT)
- Where
- 2 sites in United States, Sweden
- Volunteers
- 175 people
- Sponsor
- GE Healthcare
Urothelial Carcinoma, Cholangiocarcinoma
A Study of BIND-014 in Patients With Urothelial Carcinoma, Cholangiocarcinoma, Cervical Cancer and Squamous Cell Carcinoma of the Head and Neck
BIND-014 (docetaxel nanoparticles for injectable suspension) is being studied in patients with advanced urothelial carcinoma, cervical cancer, cholangiocarcinoma or carcinomas of the biliary tree and squamous cell carcinoma of…
- Conditions
- Urothelial Carcinoma, Cholangiocarcinoma, Cervical Cancer, Squamous Cell Carcinoma of Head and Neck
- Trial name
- iNSITE2 (NCT02479178)
- Testing
- BIND-014 (docetaxel nanoparticles for injectable suspension)
- Where
- 23 sites in United States, Russia
- Volunteers
- 73 people
- Sponsor
- BIND Therapeutics
IgA Nephropathy
Clinical Study of CM338 in the Treatment of Immunoglobulin A Nephropathy
This study is a multicenter, randomized phase II clinical study to evaluate Efficacy and safety, while observing pharmacokinetic profiles, pharmacodynamic effects, and immunogenicity of CM338 in subjects with Immunoglobulin…
- Trial name
- NCT05775042
- Testing
- CM338
- Where
- China
- Volunteers
- 70 people
- Sponsor
- Keymed Biosciences Co.Ltd
PONV
Phase IIIb Study of APD421 in Combination as PONV Prophylaxis
A comparison of the efficacy of APD421 and placebo when combined with a standard anti-emetic in the prevention of PONV in patients at high risk of Post-operative Nausea and Vomiting (PONV).
- Trial name
- NCT02337062
- Testing
- APD421
- Where
- 25 sites in United States, France and 1 more
- Volunteers
- 1,147 people
- Sponsor
- Acacia Pharma Ltd
Diabetic Retinopathy
A Safety and Efficacy Study of Vitreosolve® for Non-Proliferative Diabetic Retinopathy Subjects
The purpose of this study is to determine the safety and efficacy of Vitreosolve in diabetic retinopathy patients.
- Trial name
- NCT00664183
- Testing
- Vitreosolve
- Where
- 17 sites in United States, India
- Volunteers
- 400 people
- Sponsor
- Vitreoretinal Technologies, Inc.
Solid Tumors, High Grade Gliomas
Reproducibility of 18F Uptake by Solid Tumors Using PET Imaging Following Intravenous Administration of (18F) Injection
Study aimed to assess the reproducibility of PET imaging using AH111585 (18F) Injection. Subjects are evaluable if they undergo 2 administrations of AH111585 (18F) Injection (3 to 8 days apart) and the corresponding PET…
- Conditions
- Solid Tumors, High Grade Gliomas, Lung Cancer, Head and Neck Cancer
- Trial name
- NCT00918281
- Testing
- Fluciclatide Injection
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- GE Healthcare