Clinical trials: Haemodialysis Complication
Chronic Kidney Disease
Equivalence of Calcium Acetate Oral Solution and Sevelamer Carbonate Tablets in Hemodialysis Patients
The purpose of this study is to demonstrate equivalence of calcium acetate oral solution and sevelamer carbonate in maintaining serum phosphorus levels This is a phase IV, multicenter, randomized, open-label, cross-over study to…
- Trial name
- COS-002 (NCT01427907)
- Testing
- Calcium acetate oral solution (COS), Sevelamer carbonate
- Where
- 4 sites in United States
- Volunteers
- 38 people
- Sponsor
- Fresenius Medical Care North America
Dialysis, Anemia
Study of Roxadustat (FG-4592) to Correct Anemia in Newly Initiated Dialysis Participants Not on Erythropoiesis-Stimulating Agent Treatment
The purpose of this study is to evaluate efficacy and safety of roxadustat in the correction of anemia in participants with end-stage renal disease who recently started dialysis.
- Trial name
- NCT01414075
- Testing
- Roxadustat, Oral Iron, IV Iron
- Where
- 7 sites in United States, Hong Kong and 2 more
- Volunteers
- 60 people
- Sponsor
- Kyntra Bio
End Stage Renal Disease
Evaluation of STARgraft AV for Hemodialysis Access
This study is a First-in-Human, single site, prospective, randomized, controlled evaluation of the safety and effectiveness of the Healionics STARgraft AV hemodialysis access graft.
- Trial name
- NCT03916731
- Testing
- STARgraft AV, ePTFE AV graft (control)
- Where
- Paraguay
- Volunteers
- 55 people
- Sponsor
- Healionics Corporation
Renal Impairment, End-stage Renal Disease
An Efficacy, Safety, Tolerability and Pharmacokinetics Study of 12 Weeks Treatment With Simeprevir and Daclatasvir in Participants With Chronic Hepatitis C Virus Genotype 1b or 4 Infection and Either Severe Renal Impairment or End-stage Renal Disease on Hemodialysis.
The purpose of this study is to evaluate the percentage of participants with sustained virologic response 12 weeks after the actual end of study treatment (SVR12)
- Trial name
- NCT02397395
- Testing
- Simeprevir (SMV) 150 mg, Daclatasvir (DCV) 60 mg
- Where
- 6 sites in France, Spain
- Sponsor
- Janssen R&D Ireland
Renal Failure, Renal Insufficiency
H-Guard Pilot Safety Evaluation in Haemodialysis Patients
The purpose of this research study is to find out the safety and effectiveness of a new medical device called H-Guard. During this research study, participants will receive the standard of care haemodialysis treatment, as decided…
- Conditions
- Renal Failure, Renal Insufficiency, Renal Disease
- Trial name
- NCT06070337
- Testing
- H-Guard
- Where
- United Kingdom
- Volunteers
- 8 people
- Sponsor
- Invizius Limited
Carcinoma, Renal Cell
Study of Orellanine in Metastatic Clear-Cell or Papillary Renal Cell Carcinoma
A phase I/II, open-label, study to determine the safety and preliminary efficacy of orellanine in patients with metastatic clear-cell or papillary renal carcinoma who have failed standard-of-care therapy.
- Trial name
- NCT05287945
- Testing
- Orellanine
- Where
- 10 sites in United States, France and 3 more
- Volunteers
- 75 people
- Sponsor
- Oncorena AB
Kidney Disease
Treatment for Subjects With Chronic Kidney Disease Receiving Haemodialysis
Treatment period 1:To demonstrate that switching HD subjects with a baseline haemoglobin (Hb) ≥ 10 g/dL and ≤ 13 g/dL from either subcutaneous (SC) or intravenous (IV) rHuEPO to IV darbepoetin alfa results in a mean Hb > 11 g/dL.
- Trial name
- NCT00116701
- Testing
- Aranesp®
- Volunteers
- 200 people
- Sponsor
- Amgen
Chronic Kidney Disease, End-Stage Renal Disease
The Effect of Somatropin Treatment in Adult Patients on Chronic Dialysis
This trial is conducted in Africa, Asia, Europe, North and South America and Oceania. The aim of the trial is to evaluate the effect of somatropin (human growth hormone) on survival (primary end-point; "time to death" and health…
- Trial name
- OPPORTUNITY (NCT00503698)
- Testing
- somatropin
- Where
- 381 sites in United States, Argentina and 19 more
- Volunteers
- 712 people
- Sponsor
- Novo Nordisk A/S
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.
Kidney Failure, Chronic, Renal Dialysis
Evaluating the Safety and Effectiveness of the InnAVasc Graft for Dialysis Access in Patients With Kidney Failure
The CSP-1001 study will evaluate the safety and effectiveness of the InnAVasc arteriovenous graft (AVG) when implanted in and used for hemodialysis in participants suffering from end stage renal failure (ESRD).
- Trial name
- NCT03645681
- Testing
- InnAVasc arteriovenous graft surgical implant
- Where
- 7 sites in United States
- Volunteers
- 26 people
- Sponsor
- W.L.Gore & Associates
End Stage Renal Disease, Anemia
Study of Roxadustat (FG-4592) in Participants With End-Stage Renal Disease Receiving Maintenance Hemodialysis
The primary objective of this study is to evaluate the efficacy and safety of roxadustat in participants with end-stage renal disease (ESRD) on maintenance hemodialysis (HD) therapy, previously treated with intravenous (IV)…
- Trial name
- NCT01147666
- Testing
- Roxadustat, Epoetin Alfa
- Where
- 25 sites in United States
- Volunteers
- 161 people
- Sponsor
- Kyntra Bio
Anemia, Dialysis-dependent Chronic Kidney Disease
Study of Vadadustat in Hemodialysis Participants With Anemia Switching From Epoetin Alfa
This is a Phase 2 open-label efficacy, safety, and pharmacokinetic/pharmacodynamic (PK/PD) study to evaluate oral Vadadustat for the treatment of anemia in hemodialysis participants converting from Epoetin Alfa therapy.
- Trial name
- FO2RWARD-2 (NCT03799627)
- Testing
- Vadadustat, Epoetin Alfa, Vadadustat TIW
- Where
- 41 sites in United States
- Volunteers
- 175 people
- Sponsor
- Akebia Therapeutics
Anaemia
Study of Haemodialysis Patients Switching From Aranesp to Biosimilar
The study will obtain data to show insight into clinical outcomes of patients switching from Darbepoetin Alfa to a epoetin alfa biosimilar.
- Trial name
- SHADE (NCT02191150)
- Where
- 23 sites in Australia, Bulgaria and 5 more
- Volunteers
- 272 people
- Sponsor
- Amgen
Chronic-kidney Disease Stage 5D on Stable Hemodialysis
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of VS 105
The purpose of the study is to evaluate the safety, tolerability, and PK following single and multiple ascending dose administration of VS-105 in healthy subjects and patients with chronic kidney disease stage 5D (CKD-5D) on…
- Trial name
- NCT03043482
- Where
- United States
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- Vidasym, Inc.
Chronic Kidney Disease, Secondary Hyperparathyroidism
Quality of Life in Greek Hemodialysis Patients Receiving Zemplar Intravenous
The purpose of this study is to assess health-related Quality of Life (QoL) changes in participants with chronic kidney disease (CKD) and secondary hyperparathyroidism (sHPT) undergoing hemodialysis and receiving paricalcitol…
- Trial name
- QUALITIZE (NCT01368042)
- Where
- 11 sites in Greece
- Volunteers
- 265 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Chronic Renal Failure Requiring Hemodialysis
A Phase 3, Long-Term Safety Study of Subcutaneous Epoetin Hospira in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment. AiME -Anemia Management With Epoetin
To determine the long term safety in treatment-emergent adverse events (TEAEs) of SC administration of Epoetin Hospira for maintenance of target hemoglobin (Hgb) levels in patients treated for anemia associated with chronic renal…
- Trial name
- AiME - 04 (NCT01628120)
- Testing
- Epoetin Hospira
- Where
- 115 sites in United States
- Volunteers
- 170 people
- Sponsor
- Pfizer
End Stage Renal Disease (ESRD), End Stage Renal Disease on Dialysis
EXtension of Tablo TrEatmeNt Duration Registry
Observational, retrospective and prospective, multicenter, post-market study of the Tablo Hemodialysis System in hospitalized participants with End-Stage Kidney Disease or Acute Kidney Injury who are prescribed renal replacement…
- Conditions
- End Stage Renal Disease (ESRD), End Stage Renal Disease on Dialysis, Acute Kidney Injury
- Trial name
- XTEND (NCT04912050)
- Testing
- Tablo Hemodialysis System
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Outset Medical
Chronic Kidney Disease, Hyperparathyroidism
Pediatric Chronic Kidney Disease Safety and Efficacy
The purpose of this study is to assess the safety and efficacy of adding cinacalcet to the current treatment of secondary hyperparathyroidism in children currently receiving dialysis compared to a treatment regimen that does not…
- Conditions
- Chronic Kidney Disease, Hyperparathyroidism, Hyperparathyroidism, Secondary, Kidney Disease
- Trial name
- NCT01277510
- Testing
- cinacalcet capsule, Standard of Care
- Where
- 51 sites in United States, Australia and 8 more
- Volunteers
- 43 people
- Sponsor
- Amgen
Secondary Hyperparathyroidism, Renal Insufficiency, Chronic
Effectiveness and Safety of IV Zemplar in Patients on Hemodialysis and With Secondary Hyperparathyroidism Using iPTH/100 as Initial Dose
The purpose of this study is to observe the effectiveness and safety of the use of a low initial dose regime (iPTH/100) in chronic kidney disease patients with secondary hyperparathyroidism (PTH>300pg/mL) and that require…
- Conditions
- Secondary Hyperparathyroidism, Renal Insufficiency, Chronic, Parathyroid Hormone, Hemodialysis
- Trial name
- NCT00891813
- Testing
- Zemplar (paricalcitol)
- Where
- 3 sites in Peru
- Volunteers
- 100 people
- Sponsor
- Abbott