Clinical trials: Renal Insufficiency
End Stage Renal Disease
Comparison of the Clinical Performance of 3 THERANOVA 400 Dialyzer Prototypes With a High-Flux Dialyzer in Hemodialysis Mode
The study investigates the performance of a new dialyzer (Theranova 400) containing a membrane with increased pore sizes. The performance will be determined by the removal of middle molecules (with different molecular size) from…
- Trial name
- NCT02377570
- Testing
- THERANOVA 400 dialyzer prototype AA, THERANOVA 400 dialyzer prototype BB, THERNOVA 400 dialyzer prototype CC
- Where
- Austria
- Volunteers
- 20 people
- Sponsor
- Vantive Health LLC
Graft Rejection, Kidney Failure
Study Comparing Two Sirolimus Regimens vs. Tacrolimus and Mycophenolate Mofetil Regimen in Kidney Transplant Recipients
To demonstrate the superiority of SRL + TAC elimination + corticosteroids (Group I) and SRL + MMF + corticosteroids (Group II) to TAC + MMF + corticosteroids (Group III) with respect to renal allograft function at month 12…
- Conditions
- Graft Rejection, Kidney Failure, Kidney Transplant
- Trial name
- NCT00266123
- Testing
- Sirolimus
- Volunteers
- 420 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Renal Failure, Chronic, End-Stage Renal Disease
PK of Serelaxin in Severe Renal Impairment and ESRD
The study is designed to evaluate the pharmacokinetics, safety and tolerability, immunogenicity and pharmacogenetics of a single dose of serelaxin/RLX030 in patients with severe renal impairment and end-stage-renal-disease (ESRD)…
- Trial name
- CRLX030A2102 (NCT01875523)
- Testing
- Serelaxin
- Where
- Germany
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Atherosclerosis
A Study to Assess the Pharmacokinetics, Safety and Tolerability of Repeat Oral Doses of Darapladib (SB-480848) in Subjects With Severe Renal Impairment
In accordance with the recently revised FDA draft renal impairment guidance (March 2010) which advises the conduct of renal impairment study in drugs that are not predominately eliminated through the renal route, the proposed…
- Trial name
- NCT01711723
- Testing
- Darapladib 160 mg
- Where
- 2 sites in United States
- Volunteers
- 16 people
- Sponsor
- GlaxoSmithKline
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
Critical Illness, Acute Kidney Injury
Collective Accuryn Physiologic Signals and Signatures
The CAPSS Study is a retrospective and prospective, multi-center, single-arm post-market data collection study with an FDA cleared device.
- Conditions
- Critical Illness, Acute Kidney Injury, Sepsis, Septic Shock
- Trial name
- CAPSS (NCT03817281)
- Testing
- Accuryn Monitoring System
- Where
- United States
- Sponsor
- Potrero Medical
Chronic Kidney Disease
A Study of Intermittent Oral Dosing of ASP1517 in ESA-untreated Chronic Kidney Disease Patients With Anemia
The objective of this study is to evaluate the efficacy and the safety when ASP1517 is intermittently administered in Erythropoiesis Stimulating Agent (ESA)-untreated non-dialysis chronic kidney disease patients with anemia.
- Trial name
- NCT02964936
- Testing
- roxadustat
- Where
- 38 sites in Japan
- Volunteers
- 100 people
- Sponsor
- Astellas Pharma Inc
Myelofibrosis
To Evaluate the Pharmacokinetics and Safety of TQ05105 Tablet in Renal Impairment Subjects
This is an open, open-label, parallel, single-dose, phase I clinical study designed to evaluate the pharmacokinetic (PK) profile of TQ05105 tablet in patients with renal impairment after a single dose, and to evaluate the urinary…
- Trial name
- NCT06598956
- Testing
- TQ05105
- Where
- China
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Chronic Kidney Disease + Hyperkalaemia +/- Heart Failure
Patient Palatability and Preference of 3 Potassium Binders in Patients With Chronic Kidney Disease and Hyperkalaemia
This non-interventional, Phase IV, exploratory, cross-over, randomised, single-blind, active comparator-controlled study has been designed to measure the palatability and preference of Lokelma® versus Veltassa® versus S/CPS in…
- Trial name
- APPETIZE (NCT04566653)
- Testing
- Calcium Polystyrene Sulphonate 15g/60 mL water, Lokelma® 5 g/45mL water, Lokelma® 10 g/45 mL water
- Where
- 18 sites in United States, Canada and 4 more
- Volunteers
- 147 people
- Sponsor
- AstraZeneca
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
Renal Impairment
Pharmacokinetics in Subjects With Renal Impairment
This is an open-label, non-randomized, parallel-group, mono-center, single intravenous dose, Phase I trial to investigate the Pharmacokinetic (PK) and safety of cilengitide in subjects with different grades of renal impairment as…
- Trial name
- NCT01504165
- Testing
- cilengitide 2000mg, cilengitide 1000mg, cilengitide > 1000mg and up to 2000mg
- Where
- 2 sites in Germany
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Merck KGaA, Darmstadt, Germany
End Stage Kidney Disease
Study to Evaluate the Safety, Tolerability, Efficacy and PK of IdeS in Kidney Transplantation
This study will assess the safety and efficacy of IdeS in the transplantation setting. Each patient will receive one dose of IdeS.
- Trial name
- NCT02475551
- Testing
- IdeS
- Where
- Sweden
- Volunteers
- 10 people
- Sponsor
- Hansa Biopharma AB
Chronic Kidney Disease
Open-label Pharmacokinetic Study of Iron Isomaltoside 1000 (Monofer®) Administered as Single Bolus Injections in Subjects With Stage 5 Chronic Kidney Disease on Dialysis Therapy (CKD-5D)
The purpose of this study is to assess Pharmakokinetic properties of iron isomaltoside 1000 (Monofer®) in doses of 100 mg, 200 mg or 500 mg in subjects with Stage 5 Chronic Kidney Disease on Dialysis Therapy (CKD-5D).
- Trial name
- NCT01469078
- Testing
- Monofer®
- Volunteers
- 18 people
- Sponsor
- Pharmacosmos A/S
Renal Impairment
Pharmacokinetics of IBI362 in Subjects With and Without Renal Impairment
The purpose of this study is to assess how fast IBI362 gets into the blood stream and how long it takes the body to remove it in participants with impaired kidney function compared to healthy participants.
- Trial name
- NCT05793450
- Testing
- IBI362
- Where
- China
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
End-Stage Renal Disease, End-Stage Kidney Disease
Global Study of MK-2060 (Anti-Factor XI Monoclonal Antibody) in Participants With End Stage Renal Disease Receiving Hemodialysis (FXI Hemodialysis Study) (MK-2060-007)
The purpose of this study is to evaluate the efficacy and safety of two different doses of MK-2060 (a monoclonal antibody against Factor XI) in end stage renal disease (ESRD) participants receiving hemodialysis via an…
- Conditions
- End-Stage Renal Disease, End-Stage Kidney Disease, Kidney Failure, Chronic
- Trial name
- NCT05027074
- Testing
- MK-2060
- Where
- 120 sites in United States, Argentina and 13 more
- Volunteers
- 506 people
- Sponsor
- Merck Sharp & Dohme LLC
Anaemia
Evaluation of Dose Response Relationship, Safety and Efficacy of GSK1278863 in Hemodialysis-dependent Subjects With Chronic Kidney Disease Associated Anemia
This study is intended to evaluate the dose-response relationship of GSK1278863 over the first 4 weeks of treatment and evaluate the safety and efficacy of GSK1278863 over 24 weeks to maintain hemoglobin (Hgb) level in…
- Trial name
- NCT01977482
- Testing
- GSK1278863, rhEPO
- Where
- 107 sites in United States, Australia and 14 more
- Volunteers
- 216 people
- Sponsor
- GlaxoSmithKline
Patients With Impaired Renal Function and Haemodialysis
ASP8825 - Pharmacokinetics Study in Patients With Impaired Renal Function and Haemodialysis
The objective of this study is to evaluate the pharmacokinetics and safety of ASP8825 in patients with impaired renal function and haemodialysis.
- Trial name
- NCT02629224
- Testing
- ASP8825
- Where
- 2 sites in Japan
- Volunteers
- 18 people
- Sponsor
- Astellas Pharma Inc
Pharmacokinetics
VNRX-5133 With VNRX-5022 in Subjects With Varying Degrees of Renal Impairment
This is a multi-center, open-label, PK and safety study of VNRX-5133 and VNRX-5022 when co-administered in male and female subjects with varying levels of renal impairment and healthy normal controls.
- Trial name
- NCT03690362
- Testing
- VNRX-5133 and VNRX-5022
- Where
- 2 sites in United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Venatorx Pharmaceuticals, Inc.
Acute Kidney Injury
Controlled Trial to Demonstrate a Reduction in the Number of Oliguria Events in Patients Being Managed in a Critical Care Unit, Following Cardiac Surgery, When a Novel Oliguria Prediction Tool (STABILITY UO) is Used to Identify Patients at Risk, Compared to Standard of Care.
Acute kidney injury (AKI) is experienced by 12% of patients following surgery and in up to 50% of patients following cardiac surgery.
- Trial name
- NCT05001503
- Testing
- Stability UO
- Where
- United Kingdom
- Volunteers
- 362 people, healthy volunteers welcome
- Sponsor
- Rinicare Ltd
Chronic Kidney Disease
Long-Term Follow-up of Patients With Chronic Kidney Disease Treated With Cellgram-CKD
This long-term follow-up study is a 5-year long-term follow-up study to evaluate long-term safety in Cellgram-CKD subjects. (refer to ClinicalTrials.gov. Identifier: NCT05042206).
- Trial name
- NCT05096182
- Where
- South Korea
- Volunteers
- 10 people
- Sponsor
- Pharmicell Co., Ltd.
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