Clinical trials: CKD Stage 3
Chronic Kidney Disease, Secondary Hyperparathyroidism
Evaluation of Treatment With Zemplar Capsules in the Therapy of Secondary Hyperparathyroidism (SHPT)
The aims of this post-marketing observational study (PMOS) are to evaluate the time period needed to achieve > 30% decrease of intact parathyroid hormone (iPTH) compared to the initial values and to provide data on the…
- Trial name
- NCT01224782
- Where
- 69 sites in Bulgaria, Czechia and 1 more
- Volunteers
- 994 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Chronic Renal Failure, Chronic Kidney Disease
Safety & Efficacy of Peginesatide for Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease on Hemodialysis
The purpose of the study was to evaluate the safety and efficacy of peginesatide in the maintenance treatment of anemia in participants on dialysis.
- Conditions
- Chronic Renal Failure, Chronic Kidney Disease, Anemia
- Trial name
- EMERALD 1 (NCT00597753)
- Testing
- peginesatide, Epoetin Alfa
- Where
- 89 sites in United States
- Volunteers
- 803 people
- Sponsor
- Affymax
Anemia in Incident Dialysis Patients
Safety and Efficacy Study of Roxadustat (FG-4592) for the Treatment of Anemia in End-Stage Renal Disease (ESRD) Newly Initiated Dialysis Participants
The purpose of this study is to determine whether roxadustat is safe and effective in the treatment of anemia in participants who have just begun dialysis treatment for ESRD.
- Trial name
- Himalayas (NCT02052310)
- Testing
- Roxadustat, Epoetin Alfa
- Where
- 113 sites in United States, Argentina and 13 more
- Volunteers
- 1,043 people
- Sponsor
- Kyntra Bio
Anemia of Chronic Kidney Disease
KRX-0502 (Ferric Citrate) for the Treatment of IDA in Adult Subjects With NDD-CKD
a 24-week phase 3, multi-center clinical trial, comprised of a 16-week, randomized, double-blind, placebo-controlled period ("Randomized Period"), followed by an 8-week open-label safety extension period, where all subjects…
- Trial name
- NCT02268994
- Testing
- ferric citrate
- Where
- 36 sites in United States
- Volunteers
- 234 people
- Sponsor
- Keryx Biopharmaceuticals
Renal Insufficiency, Chronic, Chronic Kidney Disease stage3
Evaluation of the Safety and Tolerability of Gemini in Subjects With Stage 3-4 Chronic Kidney Disease.
Gemini is being evaluated in a placebo controlled, single dose, escalating dose study to evaluate the safety and tolerability of intravenous Gemini in adult subjects with stage 3 or 4 chronic kidney disease.
- Conditions
- Renal Insufficiency, Chronic, Chronic Kidney Disease stage3, Chronic Kidney Disease stage4
- Trial name
- PRIME (NCT06863467)
- Testing
- Intravenous Gemini
- Where
- 3 sites in United States
- Volunteers
- 40 people
- Sponsor
- Revelation Biosciences, Inc
Renal Insufficiency, Chronic, Iron-Deficiency Anemia
Study With Oral Ferric Maltol for the Treatment of Iron Deficiency Anemia in Subjects With Chronic Kidney Disease
To evaluate the efficacy of oral ferric maltol compared with placebo in the treatment of IDA in subjects with CKD
- Trial name
- AEGIS-CKD (NCT02968368)
- Testing
- Ferric maltol
- Where
- 27 sites in United States
- Volunteers
- 167 people
- Sponsor
- Shield Therapeutics
Chronic Kidney Disease, Hyperparathyroidism, Secondary
Extension Study of CTAP101-CL-3001 or CTAP101-CL-3002
This extension study of subjects previously enrolled in studies CTAP101-CL-3001 or CTAP101-CL-3002 allows long term evaluation of the safety and efficacy of CTAP101 Capsules in reducing elevated intact parathyroid hormone (iPTH)…
- Conditions
- Chronic Kidney Disease, Hyperparathyroidism, Secondary, Vitamin D Deficiency
- Trial name
- NCT02282813
- Testing
- CTAP101 Capsules, Calcitriol, Doxercalciferol
- Volunteers
- 298 people
- Sponsor
- OPKO Health, Inc.
Non-Dialysis-Dependent Chronic Kidney Disease
Study of the Efficacy and Safety of Pegol-Sihematide for Anemia in Patients With NDD-CKD
The primary objective of this study is to evaluate the safety and efficacy of Pegol-Sihematide, as compared with recombinant human erythropoietin injection (CHO Cell), ESPO, in anemia treatment in patients with…
- Trial name
- NCT03903809
- Testing
- Pegol-Sihematide, ESPO
- Where
- China
- Volunteers
- 175 people
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Kidney Insufficiency, Secondary Hyperparathyroidism
Long-Term Therapy Outcomes When Treating Chronic Kidney Disease (CKD) Patients With Paricalcitol in German and Austrian Clinical Practice
The purpose of this study is to obtain data on the safety and effectiveness of Zemplar® (paricalcitol) injection and paricalcitol capsules in real-life clinical practice.
- Trial name
- TOP (NCT01083849)
- Where
- 87 sites in Austria, Germany
- Volunteers
- 761 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
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
Type 2 Diabetes Mellitus
A Study of the Efficacy and Safety of Ertugliflozin in Participants With Type 2 Diabetes Mellitus With Stage 3 Chronic Kidney Disease Who Have Inadequate Glycemic Control on Antihyperglycemic Therapy (MK-8835-001)
This study will evaluate the efficacy and safety of ertugliflozin (MK-8835/PF-04971729) in participants with Type 2 diabetes mellitus with Stage 3 Chronic Kidney Disease (CKD) who have inadequate glycemic control on background…
- Trial name
- NCT01986855
- Testing
- Ertugliflozin 5 mg, Ertugliflozin 10 mg
- Volunteers
- 468 people
- Sponsor
- Merck Sharp & Dohme LLC
Diabetic Kidney Disease, Chronic Kidney Diseases
Prospective Decision Impact Clinical Utility Trial of KidneyIntelX
The clinical utility trial is designed to evaluate how the results of KidneyIntelX test / platform impacts on the clinical management of type 2 diabetes patients identified as increased risk for rapid kidney function decline…
- Conditions
- Diabetic Kidney Disease, Chronic Kidney Diseases, Chronic Kidney Disease Stage 1, Chronic Kidney Disease Stage 2
- Trial name
- NCT05198284
- Testing
- KidneyIntelX
- Where
- United States
- Volunteers
- 2,000 people
- Sponsor
- Renalytix AI, Inc.
Chronic Kidney Disease, Renal Dialysis
Long-term Study in Patients With Chronic Kidney Disease and Hyperphosphatemia on Hemodialysis
This is a multi-center, open-labeled, non-comparative study to examine the safety and efficacy of ASP1585 for long-term dosing in chronic kidney disease and hyperphosphatemia patients on hemodialysis.
- Conditions
- Chronic Kidney Disease, Renal Dialysis, Renal Insufficiency, Hyperphosphatemia
- Trial name
- NCT00892749
- Testing
- ASP1585
- Where
- 4 sites in Japan
- Volunteers
- 248 people
- Sponsor
- Astellas Pharma Inc
Hemodialysis Patients With Renal Anemia
A Long Term Study of Intermittent Oral Dosing of ASP1517 in Hemodialysis Chronic Kidney Disease Patients With Anemia Converted From Erythropoieses Stimulating Agent (ESA) Treatment
The objective of this study is to evaluate the efficacy and safety of ASP1517 in hemodialysis patients with renal anemia whose treatment is converted from an Erythropoieses Stimulating Agent formulation.
- Trial name
- NCT02779764
- Testing
- roxadustat
- Where
- 25 sites in Japan
- Volunteers
- 164 people
- Sponsor
- Astellas Pharma Inc
Uremic Pruritus
Phase 3 Study of Difelikefalin in Haemodialysis Chinese Adult Subjects With Moderate-to-Severe Pruritus
This a multicentre study that consists of a 12-week double-blind period, and an optional 14-week open-label extension period and a 1-week follow-up period.
- Trial name
- NCT05885737
- Testing
- Difelikefalin Injection
- Where
- 35 sites in China
- Volunteers
- 260 people
- Sponsor
- Vifor Fresenius Medical Care Renal Pharma
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
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.
Chronic Kidney Disease Requiring Chronic Dialysis
A Phase 3 Study to Investigate the Safety and Efficacy of PA21, a Phosphate Binder, in Dialysis Patients
This is a Phase 3, randomised, active controlled, multicentre study to investigate the safety and efficacy of PA21, a phosphate binder, for control of hyperphosphataemia in dialysis patients.
- Trial name
- NCT01324128
- Testing
- PA21 (2.5 g tablet containing 500 mg iron), Sevelamer carbonate, PA21-1 (1.25 g tablet containing 250 mg iron)
- Where
- 15 sites in United States, Austria and 13 more
- Volunteers
- 1,059 people
- Sponsor
- Vifor Pharma
Renal Insufficiency
Evaluation of the Risk of NSF Following MultiHance Injection in Patients With Chronic Kidney Disease
The objective of this long-term study is to prospectively compare the incidence of NSF in two cohorts (Cohort 1 - patients with moderate chronic kidney disease eGFR 30 to 59 and Cohort 2 - patients with severe chronic kidney…
- Trial name
- NCT00600951
- Where
- United States
- Volunteers
- 366 people
- Sponsor
- Bracco Diagnostics, Inc
Chronic Kidney Disease Requiring Chronic Dialysis, Hyperphosphatemia
PA21 Safety and Efficacy in Adult Chinese Subjects
This study evaluates the efficacy of PA21 in comparison with sevelamer carbonate (Renvela®) in lowering and maintaining serum phosphorus in adult Chinese subjects with CKD on dialysis after 12 weeks of treatment.
- Trial name
- NCT03644264
- Testing
- PA21, sevelamer carbonate
- Where
- China
- Volunteers
- 286 people
- Sponsor
- Vifor Fresenius Medical Care Renal Pharma