Clinical trials: CKD Stage 4
Anemia
A Study of Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) for the Treatment of Chronic Renal Anemia in Participants With Diabetic Nephropathy
This single arm, open label study will assess the efficacy, safety and tolerability of methoxy polyethylene glycol-epoetin beta for the treatment of chronic renal anemia in participants with chronic kidney disease (CKD) secondary…
- Trial name
- NCT01191983
- Testing
- Methoxy polyethylene glycol-epoetin beta [Mircera]
- Where
- 14 sites in India
- Volunteers
- 102 people
- Sponsor
- Hoffmann-La Roche
Renal Insufficiency, Chronic
A Phase III Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With CKD Stage 3b and 4 (BalanceD-CKD)
The purpose of this study is to evaluate the efficacy, safety and tolerability of balcinrenone in fixed combination with dapagliflozin, compared with dapagliflozin, in patients with CKD Stage 3b and 4 (eGFR ≥ 15 to < 45…
- Trial name
- NCT07624305
- Testing
- Balcinrenone/dapagliflozin, Dapagliflozin
- Where
- 478 sites in United States, Argentina and 25 more
- Volunteers
- 2,800 people
- Sponsor
- AstraZeneca
Anaemia
4 Week Switch Study in Hemodialysis-dependent Subjects With Anemia Associated With Chronic Kidney Disease
This is a four-week, Phase IIa, randomized, active-controlled, parallel-group, multi-center study to evaluate the safety, efficacy and pharmacokinetics of switching subjects from stable rhEPO to GSK1278863 in approximately 68…
- Trial name
- NCT01587924
- Testing
- GSK1278863, rhEPO
- Where
- 62 sites in United States, Canada and 4 more
- Volunteers
- 80 people
- Sponsor
- GlaxoSmithKline
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 Disease, Hyperparathyroidism, Secondary
Safety and Efficacy of CTAP101 to Treat Secondary Hyperparathyroidism in Stage 3 or 4 CKD and Vitamin D Insufficiency
This study will evaluate the efficacy of CTAP101 Capsules versus placebo in reducing intact parathyroid hormone (iPTH) by at least 30% from pretreatment baseline; safety and tolerability of CTAP101 will also be evaluated
- Conditions
- Chronic Kidney Disease, Hyperparathyroidism, Secondary, Vitamin D Deficiency
- Trial name
- NCT01704079
- Testing
- CTAP101 30 μg capsules, Sugar pill to CTAP101 30 μg capsules
- Where
- United States
- Volunteers
- 216 people
- Sponsor
- OPKO IP Holdings II, Inc.
Anemia
A Study of Mircera in Hemoglobin Control of Patients Transitioning to Dialysis.
This study will assess the efficacy and safety of methoxy polyethylene glycol-epoetin beta (Mircera) in the maintenance of hemoglobin levels in patients who have previously received treatment with epoetin alfa or darbepoetin…
- Trial name
- NCT00454246
- Testing
- methoxy polyethylene glycol-epoetin beta, epoetin alfa, darbepoetin alfa
- Where
- 78 sites in United States
- Volunteers
- 111 people
- Sponsor
- Hoffmann-La Roche
Healthy Volunteers
Effect of AKB-6548 on Cardiac Repolarization Intervals in Healthy Volunteers
The main purpose of this study is to evaluate the effect of single oral therapeutic and supratherapeutic doses of AKB-6548 on the QT interval.
- Trial name
- NCT02062203
- Testing
- AKB-6548 (therapeutic dose), AKB-6548 (supratherapeutic dose), Moxifloxacin
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Akebia Therapeutics
Kidney Diseases
Efficacy and Safety of Lanthanum Carbonate in Reducing Serum Phosphorus Levels in Subjects With Stage 3 and 4 Chronic Kidney Disease
Chronic kidney disease (CKD) can result in a loss of ability to filter and excrete phosphate. The body's attempt to adjust to an increased level of phosphate in the blood can result in elevated levels of hormones and minerals…
- Trial name
- NCT00234702
- Testing
- Lanthanum carbonate
- Where
- 10 sites in United States
- Volunteers
- 84 people
- Sponsor
- Shire
Chronic Kidney Disease, Hyperparathyroidism, Secondary
Safety and Efficacy of CTAP101 to Treat Secondary Hyperparathyroidism in Stage 3 or 4 CKD and Vitamin D Insufficiency
This study will evaluate the efficacy of CTAP101 Capsules versus placebo in reducing intact parathyroid hormone (iPTH) by at least 30% from pretreatment baseline; safety and tolerability of CTAP101 will also be evaluated
- Conditions
- Chronic Kidney Disease, Hyperparathyroidism, Secondary, Vitamin D Deficiency
- Trial name
- NCT01651000
- Testing
- CTAP101 30 μg capsules, Sugar pill to CTAP101 30 μg capsules
- Where
- United States
- Volunteers
- 213 people
- Sponsor
- OPKO IP Holdings II, Inc.
Secondary Hyperparathyroidism
A Phase 4, Conversion Study of Hectorol® Injection to Hectorol® Capsules in Stage 5 CKD Patients on Dialysis
Hectorol is a safe and effective treatment of secondary hyperparathyroidism in hemodialysis patients. Hectorol (doxercalciferol capsules) is indicated for the treatment of secondary hyperparathyroidism in patients with chronic…
- Trial name
- NCT00418600
- Testing
- Hectorol® (doxercalciferol capsules), doxercalciferol capsules, Hectorol®, doxercalciferol capsules, Hectorol® capsules
- Where
- 8 sites in United States
- Volunteers
- 36 people
- Sponsor
- Genzyme, a Sanofi Company
Chronic Kidney Disease stage4
Clinical Trial To Evaluate Safety And Efficacy Of KT-301 (Formerly US-APR2020) In Subjects With Chronic Kidney Disease Stage IV
The aim of this Phase 2 study is to evaluate the safety and efficacy of the live biotherapeutic product, KT-301 (formerly US-APR2020), in the management of patients with CKD Stage IV.
- Trial name
- CKD (NCT04913272)
- Testing
- US-APR2020
- Where
- 5 sites in United States
- Volunteers
- 630 people
- Sponsor
- Kibow Pharma
Chronic Kidney Disease, Hyperlipidemia
Efficacy and Safety of Simvast Controlled Release (CR) and Zocor in Chronic Kidney Disease(CKD) Stage 3, 4 and 5 Patients With Hyperlipidemia
Study design Multicenter, double-dummy, double-blinded, randomized, Phase 4 study Patients will be randomized to either a study group or a control group in a 1:1 ratio, and will be orally administered the assigned drugs Study…
- Trial name
- HM-SIM4 (NCT01564875)
- Testing
- Simvast CR, Zocor
- Where
- 7 sites in South Korea
- Volunteers
- 122 people
- Sponsor
- Hanmi Pharmaceutical Company Limited
Anemia
A Study of NeoRecormon in Patients With Chronic Kidney Disease.
This 2 arm study will compare the level of anemia, and the decline in renal function, between patients receiving NeoRecormon, and those not receiving it.
- Trial name
- NCT00437723
- Testing
- epoetin beta [NeoRecormon]
- Where
- 2 sites in Serbia
- Volunteers
- 90 people
- Sponsor
- Hoffmann-La Roche
Chronic Kidney Disease, Stage 5, Secondary Hyperparathyroidism
A Study of Zemplar® Injection and Hectorol® Injection on Intestinal Absorption of Calcium in Chronic Kidney Disease
The purpose of this study is to evaluate the effects of Zemplar® Injection and Hectorol® Injection on intestinal calcium absorption in Chronic Kidney Disease Stage 5 subjects on hemodialysis.
- Trial name
- NCT00257920
- Testing
- Zemplar® injection, Hectorol® injection
- Where
- 2 sites in United States
- Volunteers
- 41 people
- Sponsor
- Abbott
Renal Insufficiency
Evaluation of the Risk of Nephrogenic Systemic Fibrosis (NSF) in Patients With Chronic Kidney Disease Without Exposure to Gadolinium Based Contrast Agents (GBCA)
The objective of this long term study is to prospectively evaluate the incidence of NSF in patients with severe CKD or kidney failure including patients undergoing dialysis (stages 4 and 5 i.e., with an eGFR below 30)who have not…
- Trial name
- NCT00773409
- Where
- United States
- Volunteers
- 405 people
- Sponsor
- Bracco Diagnostics, Inc
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
Secondary Hyperparathyroidism
A Phase 4 Pharmacokinetic Study of Hectorol Injection and Zemplar Injection in CKD Subjects on Hemodialysis
This study will measure serum levels of the active Vitamin D compound that circulates in hemodialysis subjects treated with either doxercalciferol injection (Hectorol®) or Zemplar® (paricalcitol injection).
- Trial name
- NCT00454350
- Testing
- Hectorol (doxercalciferol injection), Zemplar (Paricalcitol injection)
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Genzyme, a Sanofi Company
Chronic Kidney Diseases
A Study to Explore the Renal Safety of Visipaque Injection 320 mgI/mL in Patients With Chronic Kidney Disease
This parallel-group, randomized, placebo-controlled study will examine the incidence and severity of acute kidney injury (AKI) in patients with chronic kidney disease (CKD) stage III/IV following an i.v.
- Trial name
- NCT03119662
- Testing
- Visipaque
- Where
- 29 sites in United States, Belgium and 4 more
- Volunteers
- 4 people
- Sponsor
- GE Healthcare
Chronic Kidney Disease, Left Ventricular Hypertrophy
The PRIMO Study: Paricalcitol Capsules Benefits Renal Failure Induced Cardiac Morbidity in Subjects With Chronic Kidney Disease Stage 3/4
To evaluate the effects of paricalcitol capsules on cardiac structure and function over 48 weeks in patients with Stage 3/4 chronic kidney disease (CKD) who had left ventricular hypertrophy (LVH).
- Trial name
- PRIMO (NCT00497146)
- Testing
- paricalcitol
- Where
- 71 sites in United States, Australia and 10 more
- Volunteers
- 227 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Kidney Diseases, Coronary Artery Disease
A Study of the Safety and Tolerance of Regadenoson in Subjects With Renal Impairment
This study is intended to assess the safety and tolerance of regadenoson in subjects with renal impairment.
- Trial name
- NCT00863707
- Testing
- Regadenoson
- Where
- 41 sites in United States
- Volunteers
- 511 people
- Sponsor
- Astellas Pharma Inc