Clinical trials: End Stage Disease
End-Stage Renal Disease Requiring Haemodialysis
To Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of KN060 in ESRD Dialysis Patients
The primary objective of this study is to assess the safety and tolerability of KN060 in patients with end-stage renal disease on regular hemodialysis.
- Trial name
- NCT07201467
- Testing
- KN060
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Suzhou Alphamab Co., Ltd.
Myelofibrosis
PK of Pacritinib in Patients With Mild, Moderate, Severe Renal Impairment and ESRD Compared to Healthy Subjects
This is a Phase 1 open label, single dose, 5 parallel-group study in which a single 400 mg dose of pacritinib will be administered orally to patients with renal impairment (mild, moderate, severe, and patients with ESRD requiring…
- Trial name
- NCT02807077
- Testing
- Pacritinib
- Where
- 3 sites in Germany, Moldova and 1 more
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- CTI BioPharma
End Stage Renal Disease
Pharmacokinetics, Safety and Tolerability of Aliskiren (SPP100) in Patients With End Stage Renal Disease on Hemodialysis and Matched Healthy Subjects
This study will assess the pharmacokinetics, safety and tolerability of aliskiren in healthy subjects and patients with End Stage Renal Disease on hemodialysis.
- Trial name
- NCT01568775
- Testing
- Aliskiren
- Where
- Germany
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Novartis
Cystic Fibrosis
Safety and Efficacy of Ataluren (PTC124) for Cystic Fibrosis
In some participants 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
- NCT00237380
- Testing
- Ataluren
- Where
- Israel
- Volunteers
- 24 people
- Sponsor
- PTC Therapeutics
Bullous Pemphigoid (BP), Cold Agglutinin Disease (CAD)
Safety, Tolerability and Activity of BIVV009 in Healthy Volunteers and Patients With Complement Mediated Disorders
Prospective, double-blind, randomized, placebo-controlled First-In-Human study with four sub-parts: Part A, a single ascending dose study (SAD) in normal human volunteers (NHVs), Part B, a multiple ascending dose study (MAD) in…
- Conditions
- Bullous Pemphigoid (BP), Cold Agglutinin Disease (CAD), Warm Autoimmune Hemolytic Anemia (WAIHA), End-stage Renal Disease (ESRD)
- Trial name
- BIVV009-01 (NCT02502903)
- Testing
- BIV009
- Where
- Austria
- Volunteers
- 122 people, healthy volunteers welcome
- Sponsor
- Bioverativ, a Sanofi company
Renal Failure, End Stage Renal Disease
Safety and Clinical Performance of a Dialyzer With a Modified Polysulfone Membrane
The clinical investigation will be performed to generate clinical data on clearances and removal rates (for ß2-microglobulin, myoglobin, phosphate, creatinine, and urea) as well as biocompatibility of the modified polysulfone…
- Trial name
- eMPORA (NCT03315624)
- Testing
- Dialyzer
- Where
- Germany
- Volunteers
- 49 people
- Sponsor
- Fresenius Medical Care Deutschland GmbH
Renal Replacement Therapy
Blood Viscosity, End-Stage Renal Disease, And Mortality (BEAM-1)
Prospective, real-time observational study of hemodialysis patients treated with erythropoiesis-stimulating agents (ESA) to currently recommended Hgb targets.
- Trial name
- BEAM-1 (NCT01023893)
- Volunteers
- 400 people
- Sponsor
- ProMetrics, Inc.
End Stage Renal Disease (ESRD)
Product Evaluation for the Effectiveness of the ClearGuard™ HD End Cap
To assess positive blood cultures (PBCs) in hemodialysis central venous catheter (CVC) patients using two FDA cleared devices: ClearGuard HD end caps compared to conventional end caps.
- Trial name
- NCT02604264
- Testing
- ClearGuard HD end cap
- Where
- United States
- Volunteers
- 2,912 people
- Sponsor
- Pursuit Vascular, Inc.
Ovarian Neoplasms
Efficacy and Safety Study of ZK219477 in Patients With Recurrent Ovarian Cancer
The purpose of this study is to determine if this epothilone leads to a response in patients with recurrent ovarian cancer that has progressed during, or in the last six months since a treatment of platinum-based chemotherapy.
- Trial name
- NCT00246688
- Testing
- Sagopilone (BAY86-5302 , ZK219477)
- Volunteers
- 63 people
- Sponsor
- Bayer
Anemia, End Stage Renal Disease
Artificial Intelligence for Optimal Anemia Management in End-stage Renal Disease: The Anemia Control Model (ACM) Trial
Fresenius Medical Care has developed a computer software programme called the Anaemia Control Management (ACM) software to assist in the anaemia management of patients with chronic kidney disease (CKD) undergoing hemodialysis.
- Trial name
- ANEMEX (NCT03214627)
- Testing
- Anemia Control Model (ACM), IV iron, Erythropoiesis-Stimulating Agent (ESA)
- Where
- United Kingdom
- Volunteers
- 88 people
- Sponsor
- Vifor Fresenius Medical Care Renal Pharma
End Stage Renal Disease, Chronic Kidney Disease Stage 5
Pharmacodynamic Study of AZD1722 in End-stage Renal Disease Patients on Hemodialysis
The purpose of this study is to determine if the study drug is safe, tolerable and active in reducing fluid overload/weight gain between dialysis sessions for patients with End Stage Renal Disease on Hemodialysis.
- Conditions
- End Stage Renal Disease, Chronic Kidney Disease Stage 5, ESRD
- Trial name
- NCT01764854
- Testing
- AZD1722 (in-patient), AZD1722 (out-patient)
- Where
- 3 sites in United States
- Volunteers
- 88 people
- Sponsor
- Ardelyx
Kidney Failure, Chronic
Pharmacokinetics and Safety of Alisporivir in Subjects With End Stage Renal Disease on Hemodialysis Compared to Healthy Subjects
The primary objective of the study was to compare the single dose pharmacokinetics of alisporivir in subjects with end stage renal disease (ESRD) on hemodialysis to those of matched healthy subjects.
- Trial name
- NCT01975337
- Testing
- Alisporivir
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Debiopharm International SA
Renal Failure, End Stage Renal Disease
Comparison of Efficacy and Tolerability of APD Treatment With Different PD Cyclers
The study has been designed in order to investigate the performance and safety of the new Silencia PD cycler including the Silencia tubing system in comparison to the PD-Night and Homechoice PD cycler which are both…
- Trial name
- NCT04749680
- Testing
- PD cycler Silencia
- Where
- 4 sites in Chile
- Volunteers
- 16 people
- Sponsor
- Fresenius Medical Care Deutschland GmbH
End Stage Renal Disease, Hyperparathyroidism, Secondary
Mineral and Bone Disorders Outcomes in Stage 5D of Chronic Kidney Disease
The MBD-5D is a prospective observational study with a case-cohort and a cohort design. Eligible patients are receiving hemodialysis and have secondary hyperparathyroidism.
- Trial name
- MBD-5D (NCT00995163)
- Where
- Japan
- Volunteers
- 8,020 people
- Sponsor
- Kyowa Kirin Co., Ltd.
Renal Impairment
Pharmacokinetics (PK) and Safety of a Single Intravenous (IV) Dose of MK-3866 in Participants With Impaired Renal Function and in Healthy Controls (MK-3866-005)
The purpose of this study is to compare plasma and urine PK parameters of MK-3866 between participants with impaired renal function and healthy control participants, to investigate the extent to which MK-3866 is removed from the…
- Trial name
- NCT03259087
- Testing
- MK-3866
- Where
- 2 sites in United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Staphylococcus Aureus Infection
A Study to Evaluate the Safety and Immunogenicity of V710 in Adults With Kidney Disease on Hemodialysis (V710-005)(COMPLETED)
This is a study to evaluate the safety and immunogenicity of V710 with and without Merck Aluminum Adjuvant (MAA) in adult participants with end-stage kidney disease who are on hemodialysis.
- Trial name
- NCT00572910
- Volunteers
- 206 people
- Sponsor
- Merck Sharp & Dohme LLC
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
ESRD (End Stage Renal Disease)
Fluid Status of ESRD Patients Undergoing Dialysis
The pilot clinical study will assess the correlation between fluid removal during dialysis and HemoCept device data.
- Trial name
- NCT07217470
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- HemoCept Inc.
Dry Eye Disease Associated to Asthenopia and Accommodative Effort in Video Display Terminal Users
Evaluation of Performance and Safety of Eye Drops With Hydroxypropyl-methylcellulose and Inositol in Drye Eye Disease
This is a profit, multicentric, prospective, single-arm, open-label, non-pharmacological clinical investigation. Patients with diagnosis of moderate to severe dry eye disease with asthenopia and accommodative effort will receive…
- Trial name
- NCT06190054
- Testing
- MERAMIRT
- Where
- 4 sites in Italy
- Volunteers
- 100 people
- Sponsor
- Fidia Farmaceutici s.p.a.
B-Cell Acute Lymphoblastic Leukemia
Study of Efficacy and Safety of Tisagenlecleucel in HR B-ALL EOC MRD Positive Patients
This is a single arm, open-label, multi-center, phase II study to determine the efficacy and safety of tisagenlecleucel in de novo HR pediatric and young adult B-ALL patients who received first-line treatment and are EOC MRD…
- Trial name
- CASSIOPEIA (NCT03876769)
- Testing
- CTL019
- Where
- 43 sites in United States, Belgium and 9 more
- Volunteers
- 121 people
- Sponsor
- Novartis Pharmaceuticals