Clinical trials: Kidney Insufficiency
Renal Impairment
Evaluation of Effect of Renal Impairment on the PK of Tenofovir Exalidex
This is a Phase 1 study to investigate the effects of Renal Impairment on the pharmacokinetics of Tenofovir exalidex
- Trial name
- NCT03284164
- Testing
- Tenofovir Exalidex (TXL)
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- ContraVir Pharmaceuticals, Inc.
Chronic Kidney Disease, Type 2 Diabetes
A Pharmacodynamic Study of Measured Glomerular Filtration Rate in Patients With Chronic Kidney Disease and Type 2 Diabetes
This is a 24-week multi-center, double-blind, randomized, exploratory study of bardoxolone methyl treatment in 18 patients with Stage 3 CKD (eGFR greater than or equal to 30.0 to less than 60.0 ml/min/1.73m2) and diabetes to…
- Trial name
- NCT01500798
- Testing
- 20 mg bardoxolone methyl
- Volunteers
- 18 people
- Sponsor
- Biogen
Chronic Kidney Disease
Observational Study of Kibow Biotics in Chronic Kidney Failure Patients on Dialysis
A specifically formulated probiotic product comprised of defined and tested microbial strains may afford renoprotection in what has been generally called "Enteric DialysisTM".
- Trial name
- NCT01450709
- Testing
- Kibow Biotics
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Kibow Pharma
Renal Insufficiency
A Study of Lanabecestat in Participants With Severe Kidney Impairment Compared to Healthy Participants
The purpose of the study is to determine whether lanabecestat can be safely prescribed in participants with kidney impairment without a dose adjustment.
- Trial name
- NCT03545087
- Testing
- Lanabecestat, Iohexol
- Where
- 3 sites in United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Obesity
Study Examining The Effect Of Renal Impairment On Safety, Toleration And How The Body Processes An Experimental Drug
CP-945,598 is eliminated following extensive metabolism. For some drugs, decreased renal (kidney) function can affect their elimination from the body via metabolism.
- Trial name
- NCT00472836
- Testing
- CP-945,598
- Where
- 2 sites in United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy Volunteers
A Phase I Study Comparing the Safety, Pharmacokinetics and Renal Effects of VRP-034 and Marketed Polymyxin B in Healthy Volunteers
This is a Phase 1, single-center, randomized, double-blind, active-controlled clinical study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and nephrotoxicity attenuation potential of VRP-034 compared with…
- Trial name
- VRP-034 (NCT07502144)
- Testing
- VRP-034 (Polymyxin B 500,000 IU), Commercially available Polymyxin B 500,000 IU (Poly-MxB)
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Venus Remedies Limited
Chronic Kidney Disease (CKD)
A Phase 3b Study of Erythropoietin Drugs Using a Specified Dosing Algorithm in Patients With Chronic Kidney Disease on Hemodialysis
A phase 3b study for subjects receiving Epogen to compare a dosing algorithm between Hospira Epoetin and Standard of Care Epogen.
- Trial name
- NCT02504294
- Testing
- Epoetin Hospira Arm, Standard of Care Arm, IV Iron
- Where
- 45 sites in United States, Puerto Rico
- Volunteers
- 432 people
- Sponsor
- Pfizer
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
End-Stage Renal Disease (ESRD), End-Stage Kidney Disease (ESKD)
Single Dose Study of MK-2060 to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Older Japanese Participants on Dialysis (MK-2060-012)
The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of MK-2060 after a single dose intravenous (IV) administration in Japanese older participants with end stage renal…
- Conditions
- End-Stage Renal Disease (ESRD), End-Stage Kidney Disease (ESKD), Kidney Failure, Chronic
- Trial name
- NCT05769595
- Testing
- MK-2060
- Where
- 12 sites in Japan
- Volunteers
- 17 people
- Sponsor
- Merck Sharp & Dohme LLC
Chronic Kidney Disease (CKD), Hyperkalemia (HK)
A Two-Part, Single-Blind, Phase 3 Study Evaluating the Efficacy and Safety of Patiromer for the Treatment of Hyperkalemia (OPAL)
The purpose of this study was to evaluate the efficacy and safety of patiromer (investigational drug) in the treatment of hyperkalemia (high serum potassium).
- Trial name
- OPAL (NCT01810939)
- Testing
- Patiromer
- Where
- 58 sites in United States, Croatia and 8 more
- Volunteers
- 243 people
- Sponsor
- Relypsa, Inc.
Subjects With Renal Impairment, Healthy Subjects
A Study in Subjects With Renal Impairment Compared to Subjects With Normal Renal Function
The purpose of this study is to evaluate the pharmacokinetics and safety of a single dose of JT001 in adult subjects with mild and moderate renal impairment compared to healthy mean-matched subjects.The results of this study will…
- Trial name
- NCT05895812
- Testing
- Deuremidevir Hydrobromide Tablets
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Shanghai Vinnerna Biosciences Co., Ltd.
Cerebral Hemorrhage, Head Injury
Biomarkers Correlation With Volemia
The purpose of this study is to determine whether the Biomarkers (pro adrenomedullin (MR proADM), pro arginin vasopressin (CT proAVP), pro atrial natriuretic peptid (MR proANP), Pro Endothelin) changes at Day 2, Day 5 and Day 7…
- Conditions
- Cerebral Hemorrhage, Head Injury, Non Traumatic Post Surgery, Poly Trauma Patients Without Heart Failure
- Trial name
- ENVOL (NCT01858675)
- Testing
- Biomarkers, red blood cells and plasma assessment
- Where
- France
- Volunteers
- 66 people
- Sponsor
- ThermoFisher Scientific Brahms Biomarkers France
Renal Impairment
A Pharmacokinetic Study of TRK-100STP in Japanese Patients With Renal Impairment
The PK and safety profiles to be examined following a single oral administration of TRK-100STP (120 μg) under fasting conditions to patients with renal impairment and to subjects with normal renal function.
- Trial name
- NCT01443429
- Testing
- beraprost sodium(BPS)
- Where
- Japan
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Toray Industries, Inc
Chronic Kidney Disease, Hyperphosphatemia
An Open Label Dose Titration of Sevelamer Carbonate Tabs 3 Times a Day in Hyperphosphatemic CKD Patients Not On Dialysis
Approximately 45 hyperphosphatemic CKD patients not on dialysis will be entered into this study at approximately 20 sites within Europe and 5-10 in Australia.
- Trial name
- NCT00681941
- Testing
- Sevelamer carbonate (Renvela®)
- Where
- 25 sites in Australia, Denmark and 3 more
- Volunteers
- 49 people
- Sponsor
- Genzyme, a Sanofi Company
Chronic Kidney Disease, Chronic Renal Insufficiency
STAAR-1 Clinical Study
To assess the effect of Aranesp on the hemoglobin of CRI subjects who are recombinant human erythropoetin (rHuEPO)-naïve or converting from rHuEPO therapy
- Conditions
- Chronic Kidney Disease, Chronic Renal Insufficiency, Kidney Disease, Pre-dialysis
- Trial name
- NCT00369772
- Testing
- darbepoetin alfa
- Volunteers
- 2,000 people
- Sponsor
- Amgen
Anemia, Chronic Kidney Disease
A Study of the Efficacy and Safety of MK2578 for the Treatment of Anemia in Patients With Kidney Disease (MK2578-003-AM03-EXT12)
This study will evaluate the efficacy and safety of intravenous MK2578, given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving erythropoietin stimulating…
- Trial name
- NCT00924781
- Testing
- MK2578 1mcg for every 600 Units (U) of Epogen® (epoetin alfa) received per week at Baseline, MK2578 1 mcg for every 350 U of Epogen (epoetin alfa) received per week at Baseline, MK2578 1 mcg for every 200 U of Epogen (epoetin alfa) received per week at Baseline
- Volunteers
- 39 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
Chronic Kidney Disease
A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Chronic Kidney Disease
This study is open to adults with chronic kidney disease (CKD) that is at risk of getting worse. People who have taken a specific type of medication for kidney disease called SGLT2 inhibitor within 1 month before the study or…
- Trial name
- NCT06926660
- Testing
- Vicadrostat, Empagliflozin
- Where
- 157 sites in United States, Argentina and 22 more
- Volunteers
- 492 people
- Sponsor
- Boehringer Ingelheim
Renal Insufficiency / Therapy
PD Catheter Data Collection
Peritoneal Dialysis (PD) is a Renal Replacement Therapy for patients with renal insufficiency that has been used more frequently in recent years.
- Trial name
- Catheter (NCT07156123)
- Where
- 2 sites in Germany
- Volunteers
- 300 people
- Sponsor
- Fresenius Medical Care Deutschland GmbH
Anemia, Renal Insufficiency, Chronic
Long-term Pre-dialysis Extension in Europe and Asia Pacific
Anaemia is a condition in which blood has a lower than normal number of red blood cells. It can also occur if red blood cells do not contain enough haemoglobin, an oxygen carrying part of blood.
- Trial name
- DIALOGUE 3 (NCT02055482)
- Testing
- Molidustat (BAY85-3934), Darbepoetin
- Where
- 105 sites in Australia, Bulgaria and 12 more
- Volunteers
- 166 people
- Sponsor
- Bayer
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