Clinical trials: Dialysis
Uremic Pruritus
A Study to Evaluate the Safety and Efficacy of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus (KALM-1)
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of intravenous (IV) CR845 at a dose of 0.5 mcg/kg administered after each dialysis session.
- Trial name
- NCT03422653
- Testing
- CR845 0.5 mcg/kg
- Where
- 57 sites in United States
- Volunteers
- 378 people
- Sponsor
- Cara Therapeutics, Inc.
Chronic Kidney Disease
Study to Evaluate the Prospective Payment System
To describe trends in treatment patterns of Small Dialysis Organizations (SDOs) prior to and during the implementation of the Centers for Medicare and Medicaid Services' (CMS') policy [End Stage Renal Disease (ESRD) Prospective…
- Trial name
- STEPPS™ (NCT01717989)
- Where
- 41 sites in United States, Puerto Rico
- Volunteers
- 2,248 people
- Sponsor
- Amgen
Kidney Failure, Chronic
Deprescribing for Older Dialysis Patients
Aim 1 of the study is to identify the elements of a deprescribing intervention that address contextual factors specific to dialysis.
- Trial name
- NCT03631290
- Testing
- Deprescribing Intervention
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- Duke University
Anemia
A Study of Mircera (C.E.R.A.) in Patients With Pre-Dialysis Chronic Renal Anemia
This single arm, open label, multicenter study will evaluate the safety and change in hemoglobin levels of Mircera (C.E.R.A.; methoxy polyethylene glycol-epoetin beta) in patients with chronic renal anemia who are not on…
- Trial name
- NCT01342640
- Testing
- methoxy polyethylene glycol-epoetin beta [Mircera]
- Where
- 5 sites in Egypt
- Volunteers
- 70 people
- Sponsor
- Hoffmann-La Roche
Anemia
A Study of MIRCERA for the Intrapetient Variability of Hemoglobin Levels in Patients With Chronic Renal Anemia (RIVAL)
This retrospective observational study will assess the incidence of hemoglobin cycling in chronic kidney disease (stage 3, 4, and 5) patients with renal anemia treated with Mircera (methoxy polyethylene glycol-epoetin beta).
- Trial name
- NCT01356589
- Where
- 33 sites in Greece
- Volunteers
- 1,288 people
- Sponsor
- Hoffmann-La Roche
Chronic Kidney Diseases
An Observational Study of Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) in Chronic Kidney Disease Participants on Dialysis
This observational, multi-center, open-label, prospective study will evaluate the relationship between serum interleukin-6 (IL-6) and C-reactive protein (CRP) levels and methoxy polyethylene glycol-epoetin beta dosage in…
- Trial name
- IMPACT (NCT02238080)
- Testing
- Methoxy Polyethylene Glycol-Epoetin Beta
- Where
- 18 sites in Israel
- Volunteers
- 197 people
- Sponsor
- Hoffmann-La Roche
CKD Anemia
A Study of Roxadustat for the Treatment of Anemia in Participants With Chronic Kidney Disease and Not Receiving Dialysis
The purpose of this study is to determine whether roxadustat is safe and effective in the treatment of anemia in participants with chronic kidney disease and not on dialysis.
- Trial name
- NCT01750190
- Testing
- Roxadustat
- Where
- 145 sites in United States, Argentina and 14 more
- Volunteers
- 922 people
- Sponsor
- Kyntra Bio
Chronic Kidney Disease, Dialysis
A Study of MCI-196 in Chronic Kidney Disease Subjects on Dialysis With Hyperphosphatemia and Dyslipidaemia
This is a phase III multi-centre study in two periods: the first period is a phosphate binder and lipid lowering drugs washout for 8 weeks, the second period is a double-blind, randomised, parallel group, fixed dose, for 12 weeks.
- Conditions
- Chronic Kidney Disease, Dialysis, Hyperphosphatemia, Dyslipidemia
- Trial name
- NCT00542386
- Testing
- MCI-196
- Where
- 73 sites in Hungary, Italy and 6 more
- Volunteers
- 642 people
- Sponsor
- Tanabe Pharma Corporation
Advance Care Planning, Chronic Kidney Diseases
Integrating Conservative Kidney Management Options and Advance Care Planning Into a Pre-Dialysis Educational Program
The goals of this work will be to evaluate the preliminary efficacy of a comprehensive pre-dialysis education program on increased knowledge of conservative kidney management and advance care planning among patients with advanced…
- Conditions
- Advance Care Planning, Chronic Kidney Diseases, Conservative Kidney Management
- Trial name
- NCT03229811
- Testing
- ESRD education + conservative kidney management and ACP education
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- University of Pennsylvania
Secondary Hyperparathyroidism
Safety, Tolerability and Efficacy of Etelcalcetide in Hemodialysis Patients With Secondary Hyperparathyroidism
The purpose of this study is to characterize the safety and tolerability and efficacy of multiple ascending doses of etelcalcetide in hemodialysis patients for the treatment of secondary hyperparathyroidism (HPT).
- Trial name
- NCT01254565
- Testing
- Etelcalcetide
- Where
- 13 sites in United States
- Volunteers
- 87 people
- Sponsor
- KAI Pharmaceuticals
Anemia
A Study of Monthly Subcutaneous or Intravenous Mircera in Dialysis Patients With Chronic Renal Anaemia
This open label, single arm study will assess the efficacy for long-term maintenance of haemoglobin levels and the safety and tolerability of methoxy polyethylene glycol-epoetin beta [Mircera] in dialysis patients with chronic…
- Trial name
- NCT01156363
- Testing
- Dialysis, methoxy polyethylene glycol-epoetin beta [Mircera]
- Where
- 3 sites in Taiwan
- Volunteers
- 86 people
- Sponsor
- Hoffmann-La Roche
Anemia
OPTIMA: An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Participants With Chronic Kidney Disease Stages 3 and 4 Not on Dialysis
This prospective observational study evaluated the efficacy and safety of Mircera (methoxy polyethylene glycol-epoetin beta) in chronic kidney disease participants on dialysis with renal anemia.
- Trial name
- OPTIMA (NCT01902628)
- Where
- 24 sites in Greece
- Volunteers
- 437 people
- Sponsor
- Hoffmann-La Roche
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
Renal Failure, End Stage Renal Disease
Safety and Efficacy Assessment of HAV in Patients Needing Vascular Access for Dialysis
This is a Phase 2, prospective, multicenter, open-label, single-arm study of the Human Acellular Vessel (HAV).
- Conditions
- Renal Failure, End Stage Renal Disease, Vascular Access, Hemodialysis
- Trial name
- NCT04135417
- Testing
- HAV
- Where
- 2 sites in Poland
- Volunteers
- 30 people
- Sponsor
- Humacyte, Inc.
Ulcerative Colitis
Use of Rectal Dialysis Technique to Measure Rectal 5-ASA Levels in Healthy Volunteers Receiving Asacol
The investigators plan to develop a novel method of estimating 5-ASA levels in the rectum at a mucosal level using in vivo rectal dialysis technique towards the eventual goal of determining the optimal dosing of Asacol® that…
- Trial name
- NCT04032652
- Testing
- Rectal dialysis
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- Endeavor Health
Renal Failure Chronic Requiring Dialysis, Obstructive Sleep Apnea
Effects of Compression Stockings on Obstructive Sleep Apnea in Patients Under Hemodialysis
To study the effects of compression stockings on sleep apnea in hemodialysis patients with diagnosed obstructive sleep apnea. The rationale of this study consists in the fluid shift theory, which consists in the nocturnal rostral…
- Trial name
- EComStockOSA (NCT02503215)
- Testing
- Compression Stockings
- Where
- Brazil
- Volunteers
- 14 people
- Sponsor
- University of Sao Paulo
Renal Dialysis, Kidney Failure, Chronic
Safety and Pharmacokinetics of MK-2060 in Older Participants With End-Stage Renal Disease on Hemodialysis (MK-2060-004)
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of MK-2060 after intravenous (IV) administration of single and multiple doses in older adult participants with…
- Trial name
- NCT03873038
- Testing
- MK-2060
- Where
- 3 sites in United States
- Volunteers
- 38 people
- Sponsor
- Merck Sharp & Dohme LLC
Chronic Kidney Disease
Chronic Kidney Disease Among Frail Elderly
Chronic kidney disease is a common diagnosis in the elderly population and it is associated with significant morbidity and health care costs. The prevalence rates increase with age to about 40% for adults aged > 65 years.
- Trial name
- FRED-CKD (NCT02351349)
- Testing
- multidisciplinary intervention
- Where
- Canada
- Volunteers
- 14 people
- Sponsor
- Sameena Iqbal
Cardiovascular Disease
Feasibility Study of Omega-3 Fatty Acids in Dialysis Patients
Cardiovascular disease and mortality is the largest comorbidity within the dialysis population. Nearly 50% of hemodialysis patients will have congestive heart failure at initiation.
- Trial name
- NCT01002118
- Testing
- Omega-3 Acid Ethyl Esters
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- University of Iowa
Hyperkalaemia
Study of SZC and Enhanced Nutrition Advice Compared to SoC in Dialysis Patients With Hyperkalaemia
Prescribing Sodium zirconium cyclosilicate (SZC) with enhanced nutritional advice to participants with hyperkalaemia on haemodialysis will reduce serum K+ (S-K+ ) and enable the consumption of more fruit and vegetables and more…
- Trial name
- GRAZE (NCT04997161)
- Testing
- Sodium Zirconium Cyclosilicate (SZC), Enhanced dietary advice, Standard dietary advice including K+ restriction.
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- AstraZeneca