Clinical trials: Complication of Renal Dialysis
Chronic Kidney Disease
Supplementation With Cholecalciferol in Dialysis Patients
Hypovitaminosis D is highly prevalent among patients with chronic kidney disease, especially in those undergoing dialysis. The loss of protein to the dialysis solution seems to contribute significantly to the reduced serum levels…
- Trial name
- NCT01974245
- Testing
- Cholecalciferol
- Where
- Brazil
- Volunteers
- 55 people
- Sponsor
- Federal University of São Paulo
Anemia, Anaemia
Study to Evaluate the Safety and Efficacy of GSK1278863 in Recombinant Human Erythropoietin (rhEPO) Hyporesponsive Hemodialysis-dependent Chronic Kidney Disease Subjects With Anemia
The study will evaluate the ability of GSK1278863 to increase the hemoglobin (Hgb) concentration, or maintain it within the target range, and the safety and efficacy of GSK1278863 over 16 weeks of treatment, in…
- Trial name
- NCT02075463
- Testing
- GSK1278863
- Where
- 10 sites in United States
- Volunteers
- 15 people
- Sponsor
- GlaxoSmithKline
Chronic Kidney Disease, Anemia
Study of Roxadustat in Non-Dialysis Chronic Kidney Disease Participants With Anemia
The primary purpose of this study is to evaluate efficacy and safety of roxadustat in the correction of anemia in participants with non-dialysis chronic kidney disease.
- Trial name
- NCT01244763
- Testing
- Roxadustat
- Where
- 38 sites in United States, Puerto Rico
- Volunteers
- 145 people
- Sponsor
- Kyntra Bio
End Stage Renal Disease (ESRD), Chronic Kidney Disease (CKD)
Advancing Renal TRANSplant eFficacy and Safety Outcomes With an eveRolimus-based regiMen (TRANSFORM)
This is a 2-year, randomized, multicenter, open-label, 2-arm study evaluating the graft function of everolimus and reduced CNI versus MPA and standard CNI in adult de novo renal transplant recipients.
- Conditions
- End Stage Renal Disease (ESRD), Chronic Kidney Disease (CKD), Hemodialysis, Renal Replacement Therapy
- Trial name
- TRANSFORM (NCT01950819)
- Testing
- Induction therapy, Corticosteroids, EVR+rCNI
- Where
- 184 sites in United States, Argentina and 40 more
- Volunteers
- 2,037 people
- Sponsor
- Novartis Pharmaceuticals
Secondary Hyperparathyroidism in Patients With ESRD on Hemodialysis
Pharmacokinetics and Excretion of [¹⁴C]Etelcalcetide (AMG 416) in Patients With End Stage Renal Disease (ESRD) Receiving Dialysis
The primary objectives of this study were to determine the rate, extent, and routes of radioactivity excretion of [¹⁴C]etelcalcetide in feces, dialysate, and urine over time and to measure radioactivity concentrations in whole…
- Trial name
- NCT02054572
- Testing
- [¹⁴C]Etelcalcetide
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Amgen
Anemia, Renal Failure
Heme Iron Polypeptide for Iron Deficiency Anemia in Chronic Renal Failure
The purpose of this study is to determine if oral Heme Iron Polypeptide is as effective as intravenous (IV) iron sucrose in the treatment of iron-deficiency anemia for patients with chronic kidney disease.
- Trial name
- NCT00318812
- Testing
- Heme Iron Polypeptide (Proferrin), Iron sucrose (Venofer)
- Where
- Canada
- Volunteers
- 55 people
- Sponsor
- Ottawa Hospital Research Institute
HIV-1 Infection
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of E/C/F/TAF Fixed Dose Combination (FDC) in HIV-1 Infected Adults on Chronic Hemodialysis
The primary objective of this study is to evaluate the safety and tolerability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) in human immunodeficiency virus (HIV-1)…
- Trial name
- NCT02600819
- Testing
- E/C/F/TAF, B/F/TAF
- Where
- 26 sites in United States, Austria and 2 more
- Volunteers
- 55 people
- Sponsor
- Gilead Sciences
End Stage Renal Disease on Hemodialysis (Diagnosis)
HEPLISAV-B® in Adults With End-Stage Renal Disease (ESRD) Undergoing Hemodialysis
This is an open-label, single arm study design to evaluate HEPLISAV-B® in adults with ESRD who are initiating or undergoing hemodialysis.
- Trial name
- NCT03934736
- Testing
- HEPLISAV-B®
- Where
- 20 sites in United States
- Volunteers
- 119 people
- Sponsor
- Dynavax Technologies Corporation
HIV/AIDS, ESRD
Pharmacokinetics of JULUCA in Hemodialysis
This study will compare the pharmacokinetics of the component drugs in JULUCA, and HIV combination treatment pill, in HIV-negative patients who require hemodialysis with those with normal renal function.
- Trial name
- NCT04431518
- Testing
- JULUCA 50Mg-25Mg Tablet
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Indiana University
Chronic Renal Failure
Use Of Fragmin In Hemodialysis
The study will determine if the Fragmin dose can be adjusted to suit the clinical needs of patients during dialysis.
- Trial name
- NCT01879618
- Testing
- Fragmin
- Where
- 19 sites in Canada
- Volunteers
- 152 people
- Sponsor
- Pfizer
Severe Renal Impairment
Safety, Tolerability, and Pharmacokinetic of Single Dose of Pitavastatin 4 mg in Severe Renal Patients Versus Healthy Adult Volunteers
This is a Phase 4, multicenter, open label, 1 period study. A total of 16 subjects are planned (8 subjects in Group A and 8 subjects in Group B): The 2 groups will be comparable in terms of age, gender, and body mass index (BMI)…
- Trial name
- NCT01043094
- Testing
- Pitavastatin 4mg
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Kowa Research Institute, Inc.
Hemodialysis Patient, Fatigue
The Effects of an App-based Acupressure on Alleviating Fatigue, Pruritus, and Sleep Quality Among Hemodialysis Patients
Objectives: To evaluate the effectiveness of an app-based self-guided acupressure intervention in alleviating fatigue and pruritus, and in improving sleep quality among hemodialysis patients.
- Trial name
- NCT07259369
- Testing
- app-based acupressure
- Where
- Vietnam
- Volunteers
- 60 people
- Sponsor
- Taipei Medical University
End Stage Renal Disease, Vascular Access Patency
Determine the Safety/Efficacy of Ticagrelor for Maintaining Patency of Arterio-Venous Fistulae Created for Hemodialysis
This study is a randomized, placebo-controlled, single blind clinical trial. Seventy patients with ESRD on chronic HD and a functioning AVF will be recruited.
- Trial name
- NCT02335099
- Testing
- ticagrelor
- Where
- United States
- Volunteers
- 54 people
- Sponsor
- University of Virginia
Anemia, Kidney Failure, Chronic
A Phase 2 Study of Intravenous or Subcutaneous Dosing of Sotatercept (ACE-011) in Patients With End-Stage Kidney Disease on Hemodialysis
To determine the optimal route of administration, dose level, and safety of intravenous and subcutaneous dosing of sotatercept for maintaining hemoglobin levels in subjects who are on hemodialysis.
- Trial name
- NCT01999582
- Testing
- Sotatercept
- Where
- 23 sites in Belgium, Germany and 3 more
- Volunteers
- 50 people
- Sponsor
- Celgene
End-stage Renal Disease
Use of Pedometers to Measure and Increase Walking Among Patients With ESRD
Randomized controlled trial using pedometers to increase physical activity among patients on dialysis.
- Trial name
- PED (NCT02623348)
- Testing
- pedometer
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- University of California, San Francisco
Hyperlipidemia, Mixed Dyslipidemia
Estimation Study to Assess the Effect of Severe Renal Impairment and End-stage Renal Disease Hemodialysis on the Pharmacokinetics of Evolocumab
The primary objective of this study was to evaluate the pharmacokinetics of evolocumab after a single 140 mg subcutaneous (SC) dose in aduts with normal renal function or severe renal impairment or end-stage renal disease (ESRD)…
- Trial name
- NCT02275156
- Testing
- Evolocumab
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Amgen
End Stage Renal Disease
Pharmacokinetics and Pharmacodynamics of Apixaban in Subjects on Hemodialysis
The purpose of this study is to assess the pharmacokinetics of a single oral dose of 5 mg Apixaban in subjects with normal renal function and subjects with end stage renal disease (ESRD) maintained with hemodialysis.
- Trial name
- NCT01340586
- Testing
- Apixaban
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
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
Hyperparathyroidism, Secondary, Kidney Failure, Chronic
How Vitamin D Analogues Affect Endothelial Cells in Patients on Dialysis
Patients with chronic kidney disease and end stage renal disease have greater cardiovascular risk than the general population. Vitamin D analogues have been shown in observational studies to have mortality benefit for these…
- Trial name
- NCT00528788
- Testing
- doxercalciferol
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Duke University
Anaemia
Evaluation of Dose Response Relationship, Safety and Efficacy of GSK1278863 in Hemodialysis-dependent Subjects With Chronic Kidney Disease Associated Anemia
This study is intended to evaluate the dose-response relationship of GSK1278863 over the first 4 weeks of treatment and evaluate the safety and efficacy of GSK1278863 over 24 weeks to maintain hemoglobin (Hgb) level in…
- Trial name
- NCT01977482
- Testing
- GSK1278863, rhEPO
- Where
- 107 sites in United States, Australia and 14 more
- Volunteers
- 216 people
- Sponsor
- GlaxoSmithKline