Clinical trials: CKD Stage 3
Anemia, Dialysis-Dependent Chronic Kidney Disease
Efficacy and Safety Study to Evaluate Vadadustat for the Correction or Maintenance Treatment of Anemia in Participants With Incident Dialysis-dependent Chronic Kidney Disease (DD-CKD)
A multicenter, randomized, open-label, active-controlled Phase 3 study for the correction or maintenance treatment of anemia in participants with incident dialysis-dependent chronic kidney disease (DD-CKD).
- Trial name
- NCT02865850
- Testing
- Vadadustat, Darbepoetin alfa
- Where
- 118 sites in United States, Argentina and 9 more
- Volunteers
- 369 people
- Sponsor
- Akebia Therapeutics
Hypertension, Renal Insufficiency, Chronic
A Research Study to Show Aprocitentan is Efficacious and Safe to Treat Patients With Uncontrolled Blood Pressure and Chronic Kidney Disease.
The purpose of this research study is to show the blood pressure lowering effect of aprocitentan, a new drug, when added to the background antihypertensive therapy in patients with uncontrolled blood pressure and chronic kidney…
- Trial name
- INSPIRE-CKD (NCT04162366)
- Testing
- Aprocitentan 25 mg
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Anemia
Combined Single / Multiple Dose Escalation Study in Patients With Renal Anemia Due to CKD (Chronic Kidney Disease)
The drug that is under investigation during this study is BAY85-3934 which is intended to be used as a treatment for patients suffering from renal anemia due to chronic kidney disease (stage 3 and 4).
- Trial name
- NCT01332942
- Testing
- BAY85-3934
- Where
- 11 sites in Germany, United Kingdom
- Volunteers
- 44 people
- Sponsor
- Bayer
Hyperparathyroidism, Secondary
Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis
This study is designed to assess the efficacy and safety of etelcalcetide (AMG 416) compared with placebo in the treatment of SHPT in CKD patients receiving hemodialysis.
- Trial name
- NCT01788046
- Testing
- Etelcalcetide
- Where
- 106 sites in United States, Australia and 13 more
- Volunteers
- 515 people
- Sponsor
- Amgen
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
Chronic Kidney Disease (CKD), Secondary Hyperparathyroidism (SHPT)
A Study to Evaluate Safety, Efficacy and Pharmacokinetics of Paricalcitol For Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Participants With Stage 5 Chronic Kidney Disease (CKD)
The main objective of this study is to evaluate the safety, efficacy and pharmacokinetics of paricalcitol oral solution in pediatric participants of ages 0 to 9 years with SHPT associated with stage 5 CKD receiving Peritoneal…
- Trial name
- NCT04064827
- Testing
- Paricalcitol
- Where
- 15 sites in United States, Puerto Rico
- Volunteers
- 2 people
- Sponsor
- AbbVie
Anemia, Chronic Kidney Disease
20-Week Repeat Oral Dose Study of AKB-6548 in Participants With Chronic Kidney Disease and Anemia
The purpose of this study is to evaluate the hemoglobin response (efficacy), safety, and tolerability of orally administered AKB-6548 in participants with Chronic Kidney Disease (pre-dialysis) with anemia with dosing for 20 weeks.
- Trial name
- NCT01906489
- Testing
- AKB-6548
- Where
- 47 sites in United States
- Volunteers
- 210 people
- Sponsor
- Akebia Therapeutics
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
Hyperkalemia, Chronic Kidney Disease (Stage 3-4)
AK+ Guard™ Pilot Study in Chronic Kidney Disease: Outpatient Diagnostic Accuracy and Remote Monitoring
The goal of this observational pilot study is to evaluate the investigational AK+ Guard™ software as a medical device (SaMD) for detection of moderate to severe hyperkalemia (serum potassium (K+) ≥ 6.5 mmol/L) in adults with…
- Trial name
- NCT07210021
- Testing
- AK+ Guard™ ECG Application
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- AccurKardia, Inc.
Chronic Renal Failure, Chronic Kidney Disease
A Phase 3 Study Comparing the Effects of Subcutaneous Epoetin Hospira and Epoetin Alfa [Epogen] (Amgen) in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment. AiME - Anemia Management With Epoetin
The purpose of this study is to demonstrate therapeutic equivalence of subcutaneous (SC) Epoetin Hospira compared to SC Epogen (Amgen), based on maintenance of hemoglobin (Hb) levels and study drug dose requirements in patients…
- Trial name
- AiME - 13 (NCT01473420)
- Testing
- Epoetin Hospira, Epogen Amgen
- Where
- 73 sites in United States
- Volunteers
- 320 people
- Sponsor
- Pfizer
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
Chronic Kidney Disease, Renal Insufficiency
Long-term Study in Chronic Kidney Disease Patients With Hyperphosphatemia Not on Dialysis
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 patients with hyperphosphatemia not on dialysis.
- Conditions
- Chronic Kidney Disease, Renal Insufficiency, Hyperphosphatemia
- Trial name
- NCT01742611
- Testing
- ASP1585
- Where
- 5 sites in Japan
- Volunteers
- 105 people
- Sponsor
- Astellas Pharma Inc
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 this 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 2 (NCT00597584)
- Testing
- peginesatide, Epoetin alfa or Epoetin beta
- Where
- 84 sites in United States, Bulgaria and 7 more
- Volunteers
- 823 people
- Sponsor
- Affymax
Non-diabetic Chronic Kidney Disease
A Trial to Learn How Well Finerenone Works and How Safe it is in Adult Participants With Non-diabetic Chronic Kidney Disease
Researchers are looking for a better way to treat people who have non-diabetic chronic kidney disease (non-diabetic CKD). The trial treatment, finerenone, is being developed to help people who have long lasting kidney disease…
- Trial name
- FIND-CKD (NCT05047263)
- Testing
- Finerenone (BAY94-8862)
- Where
- 326 sites in United States, Argentina and 22 more
- Volunteers
- 1,584 people
- Sponsor
- Bayer
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
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.
Chronic Renal Failure Requiring Hemodialysis
A Phase 3, Long-Term Safety Study of Subcutaneous Epoetin Hospira in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment. AiME -Anemia Management With Epoetin
To determine the long term safety in treatment-emergent adverse events (TEAEs) of SC administration of Epoetin Hospira for maintenance of target hemoglobin (Hgb) levels in patients treated for anemia associated with chronic renal…
- Trial name
- AiME - 04 (NCT01628120)
- Testing
- Epoetin Hospira
- Where
- 115 sites in United States
- Volunteers
- 170 people
- Sponsor
- Pfizer
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
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
Obesity
A Study to Test the Effect of Survodutide (BI 456906) on Cardiovascular Safety in People With Overweight or Obesity (SYNCHRONIZE™ - CVOT)
This study is open to adults who are at least 18 years old and have a body mass index (BMI) of 27 kg/m2 or more. People can take part if they have cardiovascular or chronic kidney disease.
- Trial name
- NCT06077864
- Testing
- survodutide
- Where
- 540 sites in United States, Argentina and 33 more
- Volunteers
- 5,531 people
- Sponsor
- Boehringer Ingelheim