Clinical trials: Complication of Hemodialysis
Kidney Failure, Chronic
Study to Compare Initial Dosing Parameters of Zemplar in Stage V Chronic Kidney Disease Subjects on Hemodialysis
To show non-inferiority in the incidence rates of elevated calcium-phosphorus product between two treatment groups: 1) a group having an initial dose based on baseline PTH (baseline iPTH/80) and 2) a group having a starting dose…
- Trial name
- NCT00091481
- Testing
- Zemplar
- Where
- 19 sites in Greece
- Volunteers
- 201 people
- Sponsor
- Abbott
Chronic Kidney Disease
Dialysis Clinical Outcomes Revisited (DCOR) Trial
This is a randomized, open-label, parallel-design study to be conducted at 75 centers within the United States. The study will be described to hemodialysis patients.
- Trial name
- NCT00324571
- Testing
- Sevelamer hydrochloride, Calcium-based phosphate binder
- Where
- 73 sites in United States, Puerto Rico
- Volunteers
- 2,000 people
- Sponsor
- Genzyme, a Sanofi Company
Dialysis; Complications, Vascular Access Complication
Access Cannulation Trial II
This is a pivotal, interventional, prospective, single-arm, open-label, multi-site clinical investigation intended to support FDA clearance of the study device based on the safety and efficacy of the device in cannulating…
- Trial name
- ACT II (NCT05490225)
- Testing
- VenaSure
- Where
- 8 sites in United States
- Volunteers
- 100 people
- Sponsor
- Voyager Biomedical
Chronic Kidney Failure
Phase III Study to Investigate the Safety and Efficacy of Fermagate and Lanthanum Carbonate
Magnesium iron hydroxycarbonate is a phosphate binder that absorbs phosphate from food, reducing the amount that the body can absorb.
- Trial name
- NCT00841126
- Testing
- Magnesium iron hydroxycarbonate, Lanthanum carbonate
- Where
- 112 sites in United States, Australia and 9 more
- Volunteers
- 657 people
- Sponsor
- Ineos Healthcare Limited
Chronic Renal Failure, Chronic Kidney Disease
A Phase 3 Study Comparing the Effects of Subcutaneous Epoetin Hospira and Epoetin Alfa [Epogen] (Amgen) in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment. AiME - Anemia Management With Epoetin
The purpose of this study is to demonstrate therapeutic equivalence of subcutaneous (SC) Epoetin Hospira compared to SC Epogen (Amgen), based on maintenance of hemoglobin (Hb) levels and study drug dose requirements in patients…
- Trial name
- AiME - 13 (NCT01473420)
- Testing
- Epoetin Hospira, Epogen Amgen
- Where
- 73 sites in United States
- Volunteers
- 320 people
- Sponsor
- Pfizer
Chronic Kidney Disease, Hemodialysis
Nicotinamide in Hemodialysis Patients With Hyperphosphatemia
Study hypothesis: Nicotinamide inhibits gastrointestinal phosphate absorption and serum phosphate levels of dialysis patients in a dose dependent manner.
- Conditions
- Chronic Kidney Disease, Hemodialysis, Hyperphosphatemia
- Trial name
- DONATO (NCT01200784)
- Testing
- Nicotinamide
- Where
- 36 sites in Germany
- Volunteers
- 252 people
- Sponsor
- Medice Arzneimittel Pütter GmbH & Co KG
Kidney Disease
Zemplar® Capsule in Reducing Serum Intact Parathyroid Hormone Levels in Chronic Kidney Disease Stage 5 Subjects on Hemodialysis or Peritoneal Dialysis
The objective of this study is to determine the safety and efficacy of Zemplar® Capsule versus placebo, in decreasing elevated intact parathyroid hormone levels in chronic kidney disease stage 5 subjects with secondary…
- Trial name
- NCT00091975
- Testing
- Zemplar Capsule
- Where
- 16 sites in United States
- Volunteers
- 78 people
- Sponsor
- Abbott
Renal Impairment
A Study to Investigate the Effect of Renal Function and Hemodialysis on the Pharmacokinetics (PK) of RO7079901
This is a multi-center, non-randomized, open-label, two-part study to investigate the effect of renal function and hemodialysis on PK of RO7079901.
- Trial name
- NCT02975388
- Testing
- RO7079901
- Where
- 5 sites in United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Patients With Impaired Renal Function and Haemodialysis
ASP8825 - Pharmacokinetics Study in Patients With Impaired Renal Function and Haemodialysis
The objective of this study is to evaluate the pharmacokinetics and safety of ASP8825 in patients with impaired renal function and haemodialysis.
- Trial name
- NCT02629224
- Testing
- ASP8825
- Where
- 2 sites in Japan
- Volunteers
- 18 people
- Sponsor
- Astellas Pharma Inc
Renal Insufficiency, Chronic, Anemia
Evaluation of Two Epoetin Alfa Dosing Strategies in Subjects With Chronic Kidney Disease Receiving Hemodialysis
The purpose of this study is to compare two different dosing methods of epoetin alfa and their effectiveness in maintaining hemoglobin levels between 10.0 to 11.0 g/dL in in patients with chronic kidney disease (CKD) receiving…
- Conditions
- Renal Insufficiency, Chronic, Anemia, Renal Dialysis, Erythrocyte Transfusion
- Trial name
- NCT02253654
- Testing
- Epoetin alfa
- Where
- 37 sites in United States, Puerto Rico
- Volunteers
- 216 people
- Sponsor
- Amgen
End-stage Renal Disease, Malnutrition; Protein
Impact of IDPN on Nutrition Markers in Patients Receiving ICHD
Evaluate the impact of intradialytic parenteral nutrition (IDPN) compounded with Clinisol, Prosol, and/or Clinolipid on albumin levels and weight in patients with end-stage renal disease (ESRD) undergoing in-center hemodialysis.
- Trial name
- NCT05439174
- Testing
- Intradialytic Parenteral Nutrition
- Where
- United States
- Volunteers
- 1,200 people
- Sponsor
- Patient Care America
Renal Failure, Chronic, End-Stage Renal Disease
PK of Serelaxin in Severe Renal Impairment and ESRD
The study is designed to evaluate the pharmacokinetics, safety and tolerability, immunogenicity and pharmacogenetics of a single dose of serelaxin/RLX030 in patients with severe renal impairment and end-stage-renal-disease (ESRD)…
- Trial name
- CRLX030A2102 (NCT01875523)
- Testing
- Serelaxin
- Where
- Germany
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
End Stage Renal Disease
Comparison of the Clinical Performance of 3 THERANOVA 400 Dialyzer Prototypes With a High-Flux Dialyzer in Hemodialysis Mode
The study investigates the performance of a new dialyzer (Theranova 400) containing a membrane with increased pore sizes. The performance will be determined by the removal of middle molecules (with different molecular size) from…
- Trial name
- NCT02377570
- Testing
- THERANOVA 400 dialyzer prototype AA, THERANOVA 400 dialyzer prototype BB, THERNOVA 400 dialyzer prototype CC
- Where
- Austria
- Volunteers
- 20 people
- Sponsor
- Vantive Health LLC
Hyperparathyroidism; Secondary, Renal
Efficacy and Safety of Cinacalcet in Ca, P and iPTH Levels in Patients With Mild, Moderate and Severe SHPT
1. To evaluate achievement ratio of iPTH,Calcium and phosphorus after taking Cinacalcet HCL in hemodialysis subjects with mild, moderate and severe SHPT; 2.
- Trial name
- ACTIVE (NCT03123406)
- Testing
- Cinacalcet HCl
- Where
- China
- Volunteers
- 750 people
- Sponsor
- Kyowa Kirin China Pharmaceutical Co., Ltd.
Multiple Myeloma, Renal Impairment
Study of Pomalidomide to Evaluate the Pharmacokinetics and Safety for Patients With Multiple Myeloma and Impaired Renal Function (POM Renal)
The purpose of this study is to determine the pharmacokinetics (PK) and safety for the combination of pomalidomide (POM) + low-dose dexamethasone (LD- DEX) in subjects with relapsed or refractory Multiple Myeloma (RRMM) and…
- Trial name
- POM Renal (NCT01575925)
- Testing
- 4 mg Oral POM + 40 mg Oral DEX, 2 mg Oral POM + 40 mg Oral DEX
- Where
- 9 sites in United States, Canada
- Volunteers
- 25 people
- Sponsor
- Celgene
Kidney Failure, Acute
Study to Evaluate the Safety and Efficacy of the Renal Assist Device in Patients With Acute Renal Failure
The purpose of this study is to evaluate the safety and efficacy of the RAD to determine whether the RAD is effective in reducing mortality in patients with Acute Renal Failure due to Acute Tubule Necrosis and to evaluate the…
- Trial name
- NCT00280072
- Testing
- Renal Assist Device
- Where
- 16 sites in United States
- Sponsor
- RenaMed Biologics
End Stage Renal Disease, Hemodialysis Patients
Association Between Dose Dialysis by Kt and Mortality
The aim of this study is to assess whether patients receiving current recommendations of an adequate dialysis dose by Kt adjusted for body surface area improved survival at 24 months compared to those who do not get it, as well…
- Trial name
- NCT01932853
- Where
- Spain
- Volunteers
- 6,129 people
- Sponsor
- NephroCare Spain
End-Stage Renal Disease
Pharmacokinetics Study of Donepezil HCl in Subjects Receiving Haemodialysis.
The purpose of this study is to investigate the pharmacokinetics of donepezil HCl 3 mg in subjects with end-state renal disease who were receiving haemodialysis.
- Trial name
- NCT01063556
- Testing
- donepezil HCl
- Where
- Japan
- Volunteers
- 6 people
- Sponsor
- Eisai Co., Ltd.
Chronic Kidney Disease (CKD)
A Prospective Clinical Evaluation of the Total Vascular Access (TVA) FLEX-1 Device Protocol FLEX-1-001
The primary objective of this clinical study is to evaluate the preliminary safety and effectiveness of using the FLEX-1 device for the creation of an arteriovenous fistula (AVF) in patients requiring chronic hemodialysis.
- Trial name
- NCT02119845
- Testing
- Endovascular AVF (EndoAVF)
- Where
- Paraguay
- Volunteers
- 16 people
- Sponsor
- C. R. Bard
Chronic Kidney Diseases, COVID-19
Observation of the Immune Response After COVID-19 Additional Vaccine Doses in Chronic Patients in Hemodialysis Therapy
Observation of humoral and cellular immune response after additional dose vaccine with different COVID-19 vaccines in ESKD patients in hemodialysis therapy.
- Conditions
- Chronic Kidney Diseases, COVID-19, Hemodialysis
- Trial name
- COVID-thIRd (NCT05142501)
- Testing
- Blood samples
- Where
- 11 sites in Portugal, Spain
- Volunteers
- 23 people
- Sponsor
- Fresenius Medical Care Deutschland GmbH