Clinical trials: Renal Dysfunction
Anemia, Kidney Disease
42-Day Repeat Oral Dose Study of AKB-6548 in Participants With Chronic Kidney Disease and Anemia
The purpose of this study is to evaluate the dose response (efficacy), pharmacodynamic response, pharmacokinetics, safety, and tolerability of orally administered AKB-6548 in pre-dialysis participants with anemia with repeat…
- Trial name
- NCT01381094
- Testing
- AKB-6548
- Where
- 28 sites in United States
- Volunteers
- 93 people
- Sponsor
- Akebia Therapeutics
Renal Impairment
Phase 1 Study of PK and Safety of HM15912 (Sonefpeglutide) in Subjects With Normal and Severe Kidney Function
An Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HM15912 in Subjects with Renal Impairment and Matched Control Subjects with Normal Renal Function
- Trial name
- NCT05711381
- Testing
- HM15912
- Where
- 4 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Hanmi Pharmaceutical Company Limited
Acute Kidney Injury
A Study of THR-184 in Patients at Risk of Developing Cardiac Surgery Associated-Acute Kidney Injury (CSA-AKI)
The purpose of this study is to determine whether THR-184 when administered around the time of cardiac surgery that requires cardiopulmonary bypass can prevent or ameliorate the development of acute kidney injury.
- Trial name
- NCT01830920
- Testing
- THR-184
- Where
- 41 sites in United States, Canada
- Volunteers
- 452 people
- Sponsor
- Thrasos Innovation, Inc.
Chronic Kidney Disease, Stage 5
Head to Head Study Against Sevelamer Hydrochloride
To compare the efficacy of Fosrenol (Lanthanum carbonate) and sevelamer hydrochloride in the reduction of serum phosphorus levels from baseline.
- Trial name
- NCT00441545
- Testing
- Fosrenol (Lanthanum Carbonate), Sevelamer hydrochloride
- Where
- 44 sites in United States, Germany and 2 more
- Volunteers
- 182 people
- Sponsor
- Shire
Secondary Hyperparathyroidism
Observational Program of Zemplar in Patients With End Stage Chronic Kidney Disease and Parathyroid Disorder on Hemodialysis in the Russian Federation
Eighty-six eligible participants with secondary hyperparathyroidism will be enrolled at thirteen sites in Russia. Planned therapy will be six months.
- Trial name
- NCT01401478
- Where
- 13 sites in Russia
- Volunteers
- 86 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Renal Insufficiency
A Study to Test How Iclepertin is Taken up in the Blood of People With and Without Kidney Problems
This study is open to people with and without kidney problems. People can join the study if they are 18 years or older and have a body mass index (BMI) between 18.5 and 35 kg/m2.
- Trial name
- NCT05718843
- Testing
- BI 425809
- Where
- Germany
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Iron Deficiency Anaemia, Chronic Kidney Disease
Ferric Carboxymaltose (FCM) Assessment in Subjects With Iron Deficiency Anaemia and Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD)
Phase IIIb study to evaluate the long-term efficacy of ferric carboxymaltose (FCM) (using targeted ferritin levels to determine dosing) or oral iron in non-dialysis-dependent chronic kidney disease (NDD-CKD) subjects with iron…
- Trial name
- FIND-CKD (NCT00994318)
- Testing
- FCM (Ferric carboxymaltose) high ferritin target, FCM (Ferric carboxymaltose) low ferritin target, Oral Iron (Ferrous sulphate)
- Where
- 19 sites in United States, Australia and 17 more
- Volunteers
- 626 people
- Sponsor
- Vifor Pharma
Pneumonia
A Study To Investigate The Pharmacokinetics, Safety And Tolerability Of An Intravenous And Oral Form Of A Compound In Subjects With Varying Degrees Of Renal Impairment And Normal Renal Function
This study will evaluate what effect renal dysfunction has on a drug that has an intravenous (CP-70,429) and an oral form (PF-03709270).
- Trial name
- NCT00759564
- Testing
- CP-70,429 and PF-03709270
- Where
- 2 sites in United States, Belgium
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Pfizer
Multiple Myeloma, Advanced Solid Tumors
Pharmacokinetics Study of Oral Ixazomib (MLN9708) in Relapsed/Refractory Multiple Myeloma and Advanced Solid Tumors Participants With Normal Renal Function or Severe Renal Impairment
The purpose of this study is to characterize the single-dose pharmacokinetic (PK) parameters of ixazomib (MLN9708) in cancer participants with either normal renal function or severe renal impairment (RI), including participants…
- Trial name
- NCT01830816
- Testing
- Ixazomib
- Where
- 11 sites in United States, Canada
- Volunteers
- 41 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
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
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
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
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