Clinical trials: End-stage Renal Failure
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
End Stage Renal Failure, Hemodialysis Access Failure
Outcomes for One-stage and Two-stage Brachial Basilic Arteriovenous Fistulas
An arteriovenous (AV) fistula is essential for patients with kidney failure on dialysis. There is no clear data on the best method to create a new brachial basilic AV fistula (BBAVF), so the choice between a single procedure and…
- Conditions
- End Stage Renal Failure, Hemodialysis Access Failure, Arterio-venous Fistula
- Trial name
- NCT04376567
- Testing
- One stage approach
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Tze-Woei Tan
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
End-stage Renal Disease
Journeys to Wellness: A Transplant Candidate Study
The purpose of this study is to determine whether telephone-adapted Mindfulness Based Stress Reduction (tMBSR) - a program of mindfulness meditation and gentle Hatha yoga delivered mostly by phone, is an effective program to…
- Trial name
- NCT01254214
- Testing
- tMBSR, Support group
- Where
- United States
- Volunteers
- 63 people
- Sponsor
- University of Minnesota
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
End Stage Kidney Disease
Continuous Glucose Monitoring in Patients With End-Stage Kidney Disease and Burnt-Out Diabetes
Twenty participants with end stage kidney disease (ESKD) and burnt-out diabetes, and 20 non-diabetic participants with ESKD will wear a continuous glucose monitoring (CGM) device for 10 days to see if the use of CGM is a better…
- Trial name
- NCT05741489
- Testing
- Continuous glucose monitoring (CGM)
- Where
- 4 sites in United States
- Volunteers
- 40 people
- Sponsor
- Emory University
End Stage Renal Disease
Inflammation, Proteolysis and IL-1 Beta Receptor Inhibition in Chronic Hemodialysis Patients
Chronic hemodialysis (CHD) patients display multiple metabolic abnormalities related to advanced uremia. Despite vigorous attempts to prevent these abnormalities and their consequences, most CHD patients suffer from a unique form…
- Trial name
- NCT00420290
- Testing
- kineret
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- Vanderbilt University
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 on Hemodialysis
Pharmacokinetics of Intravenous Difelikefalin in Chinese Adult Subjects on Haemodialysis
This is a Phase 1, single-arm, open-label study to evaluate the safety, PK, and tolerability of a repeated (3 times weekly) dose of difelikefalin administered as IV bolus injections to adult Chinese HD subjects.
- Trial name
- NCT05885763
- Testing
- Difelikefalin Injection
- Where
- 4 sites in China
- Volunteers
- 30 people
- Sponsor
- Vifor Fresenius Medical Care Renal Pharma
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
Chronic Kidney Diseases, Inflammation
Trial to Evaluate Reduction in Inflammation in Patients With Advanced Chronic Renal Disease Utilizing Antibody Mediated IL-6 Inhibition
Patients with chronic kidney disease, who have evidence of systemic inflammation with increased cardiovascular risk, will be enrolled into this trial.
- Trial name
- RESCUE (NCT03926117)
- Testing
- Ziltivekimab
- Where
- 49 sites in United States
- Volunteers
- 264 people
- Sponsor
- Novo Nordisk A/S
End-stage Renal Failure
Safety and Dialysability of Dotarem® in Dialysed Patients
To evaluate the dialysability of Dotarem®, after an IV injection of 0.1 mmol/kg in patients with chronic renal failure who require hemodialysis treatment.
- Trial name
- NCT01449266
- Testing
- Dotarem® IV injection at 0.1 mmol/kg
- Where
- Belgium
- Volunteers
- 10 people
- Sponsor
- Guerbet
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
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