Clinical trials: Renal Dysfunction
Chronic Kidney Disease
Clearance of 25-hydroxyvitamin D in Chronic Kidney Disease
The goal of this study is to better understand vitamin D catabolism and how it is affected by CKD and race.
- Trial name
- CLEAR (NCT02937350)
- Testing
- D6-25-hydroxyvitamin D3
- Where
- United States
- Volunteers
- 88 people
- Sponsor
- University of Washington
Renal Impairment, Multiple Myeloma
PK of Melphalan During Treatment With Melflufen and Dexamethasone in Patients With RRMM and Impaired Renal Function
This was a multicenter study of the pharmacokinetics (PK) of melphalan during treatment with melflufen and dexamethasone in patients with relapsed refractory multiple myeloma (RRMM) and impaired renal function.
- Trial name
- BRIDGE (NCT03639610)
- Testing
- Melflufen, Dexamethasone
- Where
- 10 sites in Czechia, Greece and 1 more
- Volunteers
- 35 people
- Sponsor
- Oncopeptides AB
Kidney Disease, Chronic
A Study to Test BI 764198 in People With a Type of Kidney Disease Called Focal Segmental Glomerulosclerosis
This study is open to adults with a type of kidney disease called focal segmental glomerulosclerosis (FSGS). The purpose of this study is to find out whether a medicine called BI 764198 improves the health of the kidneys in…
- Trial name
- NCT05213624
- Testing
- BI 764198
- Where
- 54 sites in United States, Australia and 8 more
- Volunteers
- 67 people
- Sponsor
- Boehringer Ingelheim
End-Stage Renal Disease
Study of HemoCare™ Hemodialysis System for Home Nocturnal Dialysis in Patients With ESRD
This prospective multi-center, open-label, single-arm study intends to gather and evaluate safety data for the nocturnal use of the HemoCare™ Hemodialysis System.
- Trial name
- NCT04087213
- Testing
- HemoCare™ Hemodialysis System
- Where
- 8 sites in United States
- Volunteers
- 36 people
- Sponsor
- Deka Research and Development
Kidney Transplantation, Kidney Disease
Combination Immunosuppressive Therapy to Prevent Kidney Transplant Rejection in Adults
Transplant rejection occurs when a patient's body does not recognize the new organ and attacks it. Patients who have kidney transplants must take drugs to prevent transplant rejection.
- Trial name
- NCT00078559
- Testing
- Alemtuzumab, Sirolimus, Tacrolimus
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of Wisconsin, Madison
Renal Impairment, Type 2 Diabetes Mellitus
Effect of Renal Impairment on the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Ertugliflozin in Participants With Type 2 Diabetes Mellitus (MK-8835-009)
This is a study to evaluate the effect of renal impairment on the pharmacokinetics, pharmacodynamics, safety and tolerability of ertugliflozin in participants with type 2 diabetes mellitus (T2DM) and in healthy participants with…
- Trial name
- NCT01948986
- Testing
- Ertugliflozin
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Acute Kidney Failure
Pharmacokinetics of Ertapenem in Continuous Venovenous Hemodialysis
Critically ill patients in the intensive care unit often receive continuous hemodialysis to treat their kidney failure. Ertapenem is an antibiotic often used in these patients.
- Trial name
- NCT00877370
- Testing
- ertapenem
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- University of Michigan
Neuromuscular Blockade
Dialysis of Sugammadex in Participants With Severe Renal Impairment (Study 19.4.333) (P05773)
The clinical trial objectives were to evaluate the dialysability of the sugammadex-rocuronium complex; it's safety and efficacy in participants with severe renal impairment.
- Trial name
- NCT00656799
- Testing
- sugammadex, Rocuronium
- Volunteers
- 6 people
- Sponsor
- Merck Sharp & Dohme LLC
Type 2 Diabetes Mellitus, Chronic Kidney Disease Stage 3
Safety and Efficacy Study of Sotagliflozin on Glucose Control in Participants With Type 2 Diabetes, Moderate Impairment of Kidney Function, and Inadequate Blood Sugar Control
Primary Objective: To demonstrate the superiority of Sotagliflozin 200 milligrams (mg) and Sotagliflozin 400 mg versus placebo on HbA1c reduction at 26 Weeks in participants with Type 2 diabetes who have inadequate glycemic…
- Trial name
- SOTA-CKD3 (NCT03242252)
- Testing
- Sotagliflozin
- Where
- 170 sites in United States, Argentina and 14 more
- Volunteers
- 787 people
- Sponsor
- Lexicon Pharmaceuticals
Iron Deficiency Anemia, Iron Deficiency Anaemia
An Extension Trial to Assess the Safety of Re-dosing of Iron Isomaltoside/Ferric Derisomaltose (Monofer®/Monoferric®)
Evaluate safety and efficacy of intravenous (IV) iron isomaltoside/ferric derisomaltose re-dosing, in subjects who were previously treated with iron isomaltoside/ferric derisomaltose.
- Trial name
- FERWON-EXT (NCT02962648)
- Testing
- Iron isomaltoside/ferric derisomaltose
- Where
- 22 sites in United States
- Volunteers
- 103 people
- Sponsor
- Pharmacosmos A/S
Acute Kidney Injury
IMPROVE AKI Cluster-Randomized Trial
When a person has an imaging procedure that uses radio-contrast dye, there is a possibility of damage to that person's kidneys, which could result in being on dialysis or early death.
- Trial name
- IMPROVE-AKI (NCT03556293)
- Testing
- AKI Prevention Toolkit, Technical Assistance (TA), Virtual Learning Collaborative (VLC)
- Where
- 2 sites in United States
- Volunteers
- 10,252 people
- Sponsor
- Dartmouth-Hitchcock Medical Center
Complicated Skin and Skin Structure Infections, S. Aureus Bacteremia
Study of Daptomycin Safety and Efficacy for Complicated Skin and Skin Structure Infections (cSSSI) and Bacteremia in Renal Impairment
This is a multicenter, randomized, evaluator-blinded, comparator-controlled study. Participants were to be randomized (1:1) to daptomycin or comparator, stratified by degree of renal impairment (creatinine clearance [CLcr] 30 …
- Conditions
- Complicated Skin and Skin Structure Infections, S. Aureus Bacteremia, Renal Impairment
- Trial name
- RENSE (NCT01104662)
- Testing
- Vancomycin, Daptomycin, Semi-Synthetic Penicillin
- Where
- 10 sites in United States
- Volunteers
- 92 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Anemia, Dialysis-Dependent Chronic Kidney Disease
Efficacy and Safety Study to Evaluate Vadadustat for the Correction or Maintenance Treatment of Anemia in Participants With Incident Dialysis-dependent Chronic Kidney Disease (DD-CKD)
A multicenter, randomized, open-label, active-controlled Phase 3 study for the correction or maintenance treatment of anemia in participants with incident dialysis-dependent chronic kidney disease (DD-CKD).
- Trial name
- NCT02865850
- Testing
- Vadadustat, Darbepoetin alfa
- Where
- 118 sites in United States, Argentina and 9 more
- Volunteers
- 369 people
- Sponsor
- Akebia Therapeutics
End Stage Renal Disease (ESRD), Diabetes
Dianeal, Extraneal, Nutrineal (D-E-N) Versus Dianeal Only in Diabetic Continuous Ambulatory Peritoneal Dialysis (CAPD) Patients
Primary Objective: To demonstrate that use of glucose sparing prescriptions, Dianeal, Extraneal, Nutrineal (D-E-N) versus Dianeal only, in diabetic (Type 1 and Type 2) Continuous Ambulatory Peritoneal Dialysis (CAPD) patients…
- Conditions
- End Stage Renal Disease (ESRD), Diabetes, CAPD
- Trial name
- EDEN (NCT01219959)
- Testing
- Dianeal, Dianeal, Extraneal, Nutrineal
- Where
- 16 sites in Colombia
- Volunteers
- 71 people
- Sponsor
- Vantive Health LLC
Renal Failure
Quanta Home Run Trial
The purpose of this study is to determine non-inferiority in safety and efficacy when Quanta SC+ is used in the self-care home environment compared to a hemodialysis facility.
- Trial name
- NCT04975880
- Testing
- SC+ Hemodialysis System
- Where
- 13 sites in United States
- Volunteers
- 46 people
- Sponsor
- Quanta Dialysis Technologies Ltd
Chronic Kidney Disease, Bacterial Infection
Study of the Pharmacokinetics of Daptomycin in Children With Renal Disease
The purpose of this study is to: 1. Study the pharmacokinetics and safety of daptomycin in children on hemodialysis (HD) and peritoneal dialysis (PD). 2. Determine urine, HD and PD clearance of daptomycin.
- Trial name
- NCT01012089
- Testing
- Daptomycin
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- University of Oklahoma
Anemia, Non-Dialysis-Dependent Chronic Kidney Disease
Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Participants With Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD)
A multicenter, randomized, open-label, active-controlled Phase 3 study for the maintenance treatment of anemia in participants with Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD)
- Trial name
- NCT02680574
- Testing
- Vadadustat, Darbepoetin alfa
- Where
- 503 sites in United States, Argentina and 28 more
- Volunteers
- 1,725 people
- Sponsor
- Akebia Therapeutics
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
Aspergillosis, Invasive Fungal Infections
Isavuconazole in the Treatment of Renally Impaired Aspergillosis and Rare Fungi
The purpose of this study is to investigate the efficacy and safety of isavuconazole in the treatment of renally impaired participants with invasive fungal infections caused by Aspergillus and participants with invasive fungal…
- Trial name
- VITAL (NCT00634049)
- Testing
- isavuconazole
- Where
- 96 sites in United States, Argentina and 17 more
- Volunteers
- 149 people
- Sponsor
- Astellas Pharma Inc
Renal Impairment
A Study to Determine the Pharmacokinetics, Pharmacodynamics, and Tolerabiltiy of Betrixaban in Patients With Mild, Moderate, and Severe Renal Impairment
The purpose of the study is to compare the pharmacokinetics, pharmacodynamics, and tolerability of betrixaban in patients with mild, moderate, and severe renal impairment to healthy volunteers.
- Trial name
- NCT00999336
- Testing
- Betrixaban
- Where
- Germany
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Portola Pharmaceuticals
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