Clinical trials: End Stage Disease
End Stage Renal Disease
Multicentre, Open Label, Randomized, Two-arm, Parallel-group Study to Assess Efficacy and Safety of ENVARSUS® Compared With Tacrolimus Used as Per Current Clinical Practice in the Initial Maintenance Setting in de Novo Kidney Transplant Patients
The purpose of the study is to compare tacrolimus dosing of the new Envarsus®-based immunosuppressive regimen with current clinical practice (Prograf or Advagraf) over 6 months following de novo renal transplantation in a…
- Trial name
- STEADY (NCT02432833)
- Testing
- ENVARSUS®, PROGRAF®, ADVAGRAF®
- Where
- Italy
- Volunteers
- 428 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
End-Stage Heart Failure, Cardiomyopathies
VentrAssistTM LVAD as a Bridge to Cardiac Transplantation - Feasibility Trial
The purpose of this trial is to determine the safety and feasibility of the VentrAssist LVAD in providing circulatory support for patients who require an LVAD as a bridge to cardiac transplantation.
- Trial name
- NCT00490347
- Testing
- VentrAssist Left Ventricular Assist Device
- Where
- 5 sites in United States
- Volunteers
- 30 people
- Sponsor
- Ventracor
Anemia in Chronic Kidney Disease
Effect of Hemodialysis on the PK of JTZ-951 in Subjects With End-stage Renal Disease
The purpose of this study is to evaluate the effect of hemodialysis on the pharmacokinetics (PK) of JTZ-951 and to evaluate the safety of 2 doses of JTZ-951 in subjects with end-stage renal disease (ESRD) receiving hemodialysis
- Trial name
- NCT01978587
- Testing
- JTZ-951
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Shionogi Inc.
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
Age Related Macular Degeneration
Study of WA-NG Telescope Prosthesis in Patients With End-stage Age-related Macular Degeneration
This is a pilot study to evaluate the safety of the Model WA-NG telescope prosthesis in patients with bilateral moderate to profound central vision impairment due to end-stage age-related macular degeneration.
- Trial name
- NCT01361256
- Testing
- Telescope prosthesis, WA-NG Telescope Prothesis
- Where
- Israel
- Sponsor
- VisionCare, Inc.
End Stage Renal Disease
Acid-Base Composition With Use of hemoDialysates
This study is a prospective, single center, single blind (patient and laboratory), randomized, cross-over, two week investigation of intradialytic acid-base kinetics and physiology associated with use of two commercial acid…
- Trial name
- ABChD (NCT02334267)
- Testing
- Group 1: GranuFlo, Group 2: NaturaLyte
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Fresenius Medical Care North America
Anemia Associated With End Stage Renal Disease
Study of Roxadustat Conversion in Participants Receiving Stable ESA or as Initial Anemia Treatment in Hemodialysis Participants
The purpose of this study is to assess the safety and effectiveness of roxadustat dosing regimens among hemodialysis participants converted from erythropoiesis stimulating agent (ESA) therapy or who are ESA-naïve.
- Trial name
- ASPEN (NCT04484857)
- Testing
- Roxadustat
- Where
- 26 sites in United States
- Volunteers
- 283 people
- Sponsor
- Kyntra Bio
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
Renal Impairment
Pharmacokinetics of Tasimelteon in Subjects With Renal Impairment and Matched Control Subjects With Relatively Normal Renal Function
The purpose of this research study is to understand whether there is any difference in the amount of tasimelteon (including its breakdown products) in the blood of individuals with severe renal impairment compared to individuals…
- Trial name
- NCT01526746
- Testing
- Tasimelteon
- Where
- 3 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Vanda Pharmaceuticals
Chronic Kidney Diseases, Chronic Kidney Failure
SelfWrap-Assisted Arteriovenous Fistulas
This is a single-center, prospective, single-arm clinical study to evaluate the feasibility, safety, and performance of VenoStent's SelfWrap® Bioabsorbable Perivascular Wrap on arteriovenous fistulas (AVFs).
- Conditions
- Chronic Kidney Diseases, Chronic Kidney Failure, End Stage Renal Disease, End Stage Kidney Disease
- Trial name
- SW-AVF (NCT05418816)
- Testing
- SelfWrap Bioabsorbable Perivascular Wrap
- Where
- Paraguay
- Volunteers
- 20 people
- Sponsor
- VenoStent
End-Stage Renal Disease (ESRD)
Improvement of EPO-resistance in Hemodialysis Patients With Chronic Inflammation by High Cut-off Hemodialysis
Chronic inflammation in dialysis patients is linked to cardiovascular mortality and clinical signs and symptoms, like the impaired response to erythropoiesis-stimulating agents (ESAs).
- Trial name
- CIEPO-PILOT (NCT01526798)
- Testing
- Theralite (high cut-off hemodialysis), Conventional high-flux dialyzer
- Where
- Italy
- Volunteers
- 24 people
- Sponsor
- Vantive Health LLC
Uremic Pruritus
Treatment of Uremic Pruritus With PA101B
This is a randomized, double blind, placebo-controlled, parallel-arm, multi-center, Phase 2, proof-of-concept efficacy and safety study in patients with end-stage renal disease requiring hemodialysis.
- Trial name
- NCT02696499
- Testing
- PA101B
- Where
- 13 sites in United States
- Volunteers
- 70 people
- Sponsor
- Patara Pharma
Dengue Fever
Immunogenicity and Safety of Tetravalent Dengue Vaccine (TDV) at the End of Shelf Life in Healthy Adults
The purpose of this study is to evaluate the safety and immune response of a naturally aged lot of tetravalent dengue vaccine (TDV) in healthy participants, aged 18 to 60 years, in non-endemic country(ies) for dengue.
- Trial name
- NCT03771963
- Testing
- Tetravalent Dengue Vaccine (TDV)
- Where
- 2 sites in United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Takeda
Chronic Kidney Disease, End-Stage Renal Disease
Growth Hormone Treatment in Adult Patients With Chronic Kidney Disease
This trial is conducted in Asia, Europe, and Middle East. Adult patients with chronic kidney disease are treated with growth hormone to assess effect on nutritional status.
- Trial name
- NCT00184652
- Testing
- somatropin
- Where
- 26 sites in Denmark, Germany and 7 more
- Volunteers
- 140 people
- Sponsor
- Novo Nordisk A/S
Hyperphosphatemia, End Stage Renal Disease
A Long-Term Study of Tenapanor Alone or in Combination With Sevelamer in Patients With CKD on Dialysis and HP
The study is designed to evaluate the ability of tenapanor alone or in combination with sevelamer to achieve serum phosphorus concentration (sP) within the population reference range (sP >2.5 and ≤4.5 mg/dL) in patients with…
- Trial name
- NORMALIZE (NCT03988920)
- Testing
- Tenapanor, Sevelamer Carbonate
- Where
- United States
- Volunteers
- 172 people
- Sponsor
- Ardelyx
Hyperphosphatemia, End Stage Renal Disease
Ferric Citrate for the Treatment of Hyperphosphatemia in Patients With Chronic Kidney Disease Undergoing Hemodialysis
To evaluate the efficacy and safety of ferric citrate tablet in the control of serum phosphorus levels in patients with chronic kidney disease undergoing hemodialysis.
- Conditions
- Hyperphosphatemia, End Stage Renal Disease, ESRD
- Trial name
- NCT04456803
- Testing
- Ferric citrate tablet, Sevelamer carbonate tablet
- Where
- 20 sites in China
- Volunteers
- 239 people
- Sponsor
- Sinomune Pharmaceutical Co., Ltd
Renal Disease, End Stage
PK Study of IV and Oral Amisulpride in Subjects With Severe Renal Impairment
The aim of the study is to understand how Amisulpride is taken up and distributed around the body and how quickly it is eliminated, when given by mouth and into a vein in adults with severe kidney disease.
- Trial name
- NCT04849650
- Testing
- Amisulpride IV, Amisulpride Oral Tablet
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Acacia Pharma Ltd
Cystic Fibrosis
PTC124 for the Treatment of Cystic Fibrosis
In some patients with cystic fibrosis (CF), the disease is caused by a nonsense mutation (premature stop codon) in the gene that makes the cystic fibrosis transmembrane regulator (CFTR) protein.
- Trial name
- NCT00351078
- Testing
- PTC124
- Where
- Israel
- Volunteers
- 19 people
- Sponsor
- PTC Therapeutics
Type 2 Diabetes Mellitus
A Phase 3, Randomized, Double-blind, Parallel-group, Comparative Study and a Phase 3, Multicenter, Open-label, Long-term Study of SYR-472 (25 mg) in Patients With Type 2 Diabetes Mellitus Complicated by Severe Renal Impairment or End-stage Renal Disease
The purpose of this study is to evaluate the efficacy and safety of trelagliptin when administered at a dose of 25 mg once weekly using placebo as a control in patients with type 2 diabetes mellitus complicated by severe renal…
- Trial name
- NCT02512068
- Testing
- Trelagliptin 25 mg
- Where
- 49 sites in Japan
- Volunteers
- 107 people
- Sponsor
- Takeda
Chronic Kidney Diseases, Pruritus
A Study to Evaluate the Safety and Efficacy of CR845 in Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus
This is a multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of 3 dose levels of oral CR845 compared to placebo in reducing the intensity of itch in chronic kidney disease (CKD)…
- Trial name
- NCT03617536
- Testing
- CR845 0.25 mg Oral Tablet, CR845 0.5 mg Oral Tablet, CR845 1 mg Oral Tablet
- Where
- 60 sites in United States
- Volunteers
- 269 people
- Sponsor
- Cara Therapeutics, Inc.