Clinical trials: Chronic Kidney Disease Stage 3 and 4
Hyperkalemia, Diet Modification
Sodium Zirconium Cyclosilicate to Allow Liberal Fruit and Vegetable Intake for Patients With CKD Stage 3b and 4
Rationale: Several studies have shown that higher urinary potassium excretion (as proxy for potassium intake) is associated with better kidney outcomes, lower blood pressure and improved survival.
- Conditions
- Hyperkalemia, Diet Modification, Chronic Kidney Disease, Sodium Zirconium Cyclosilicate
- Trial name
- LIBRAL (NCT06365684)
- Testing
- Sodium zirconium cyclosilicate
- Where
- Netherlands
- Volunteers
- 16 people
- Sponsor
- Leiden University Medical Center
Chronic Kidney Disease
Study to Assess the Safety and Pharmacokinetics of AKB-6548 in Participants With Chronic Kidney Disease (CKD), Stages 3 and 4
This study was conducted to assess the pharmacokinetic (PK) profile, safety, and tolerability in participants with Stage 3 and 4 Chronic Kidney Disease (CKD) following a single oral dose of Vadadustat.
- Trial name
- NCT04707573
- Testing
- Vadadustat
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- Akebia Therapeutics
Chronic Kidney Diseases
Assessing Bone Calcium Content in Children With Kidney Disease Treated With Two Different Medicines
This is an open label, time series trial. The trial is likely to be single centre (additional sites will only be opened if necessary) and will involve 25 children with chronic kidney disease (stage 3b, 4-5) or on dialysis.
- Trial name
- CAL-BAL (NCT04120922)
- Testing
- calcium carbonate, sevelamer carbonate
- Where
- United Kingdom
- Volunteers
- 21 people
- Sponsor
- University College, London
Type 2 Diabetes Mellitus, Chronic Kidney Disease Stage 4
A Study to Evaluate Safety and Effects of Sotagliflozin 400 and 200 mg on Glucose Control in Participants With Type 2 Diabetes, Severe Impairment of Kidney Function and Inadequate Blood Sugar Control
Primary Objective: To demonstrate the superiority of sotagliflozin 400 milligrams (mg) versus placebo with respect to hemoglobin A1c (HbA1c) reduction at Week 26 in participants with Type 2 diabetes who have inadequate glycemic…
- Trial name
- SOTA-CKD4 (NCT03242018)
- Testing
- Sotagliflozin
- Where
- 106 sites in United States, Argentina and 13 more
- Volunteers
- 277 people
- Sponsor
- Lexicon Pharmaceuticals
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.
CKD Stage 3, CKD Stage 4
The Iron and Muscle Study
This is a multi-center randomized controlled trial that will examine the efficacy of IV iron supplementation when compared to placebo, with and without exercise training, on changes in patient exercise capacity.
- Conditions
- CKD Stage 3, CKD Stage 4, Iron-deficiency
- Trial name
- NCT04862715
- Testing
- Ferinject
- Where
- United Kingdom
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- King's College Hospital NHS Trust
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
Fractures, Bone, CKD Stage 4
The Effect of Prophylactic Anticoagulation on Major Bleeding Events in Hospitalized Chronic Kidney Disease and Lower Limb Fracture Patients.
the risk of bleeding may be greater than the benefit of antithrombotic protection when prophylactically anticoagulating a patient with a lower limb fracture and advanced CKD.
- Conditions
- Fractures, Bone, CKD Stage 4, CKD Stage 3, CKD Stage 5
- Trial name
- FAA (NCT06795698)
- Testing
- Enoxaparin
- Where
- Mexico
- Volunteers
- 61 people
- Sponsor
- Hospital Civil de Guadalajara
Chronic Renal Failure
Change From Baseline to Chronic Kidney Disease Patient Before and After Administration Drug
Chronic renal failure is a syndrome that renal function is decreased, and the patient number is increasing. In addition, patients on dialysis have also increased.
- Trial name
- NCT02378194
- Testing
- HD-003 (800mg/day), HD-003 (1600mg/day)
- Volunteers
- 62 people
- Sponsor
- Hyundai Pharmaceutical Co., LTD.
We Investigated the Relationship Between Plasma FGF23 Levels and Endothelial Dysfunction in a Sizable Series of Incident Stage 3-4 CKD Patients.
Sevelamer, FGF-23 and Endothelial Dysfunction in Chronic Kidney Disease (CKD)
Vascular calcification and endothelial dysfunction (ED) contribute to the development of cardiovascular disease (CVD) in patients with chronic kidney disease (CKD).
- Trial name
- NCT01135615
- Testing
- Sevelamer, calcium acetate
- Where
- Turkey (Türkiye)
- Volunteers
- 100 people
- Sponsor
- Gulhane School of Medicine
Chronic Kidney Disease (Stage 3-4), Chronic Kidney Disease Mineral and Bone Disorder
Phosphate Assessment in Chronic Kidney Disease Patients Study
The proposed pilot feeding study aims to explore novel pathways in phosphate metabolism and identify new biomarkers, as well as to develop a compound index for assessing phosphate overload with high validity and reliability.
- Trial name
- PACK (NCT07368946)
- Testing
- Dietary Phosphorus Intake
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- University of Texas Southwestern Medical Center
Chronic Kidney Disease (Stage 3-4), Chronic Kidney Disease (Stages 4 and 5)
Prospective Analysis of Self Medication With Phytotherapy in Nephropatic Patients.
We propose the following hypotheses: The use of herbal medicine is common among patients with chronic kidney disease in Réunion island. This use could influence the progression of kidney disease in these patients.
- Trial name
- PASSION (NCT07444515)
- Testing
- series of questions which can change patient care
- Where
- 4 sites in France
- Volunteers
- 400 people
- Sponsor
- Centre Hospitalier Universitaire de la Réunion
Type 2 Diabetes Mellitus, Chronic Kidney Disease
Fasiglifam in Type 2 Diabetic Subjects With Chronic Kidney Disease Stage 4 or 5 on Hemodialysis
To evaluate the efficacy of fasiglifam 50 mg once daily compared to placebo on glycemic control as measured by glycosilated haemoglobin (HbA1c) over a 16-week treatment period in participants with Type 2 Diabetes Mellitus (T2DM)…
- Trial name
- NCT02015780
- Testing
- Fasiglifam, Antihyperglycemic therapy
- Where
- 30 sites in United States, Bulgaria and 5 more
- Sponsor
- Takeda
Chronic Kidney Disease (CKD) With Diabetes Mellitus (DM), CKD Stage 3
Plant-Focused Nutrition in Patients With Diabetes and Chronic Kidney Disease
In this pilot clinical trial, the investigators will recruit and randomize 120 patients with diabetes mellitus and chronic kidney disease (CKD/DM) stages 3 to 5 to a patient-centered and flexible Plant-Focused Nutrition in…
- Conditions
- Chronic Kidney Disease (CKD) With Diabetes Mellitus (DM), CKD Stage 3, CKD Stage 4, CKD Stage 5
- Trial name
- PLAFOND (NCT05514184)
- Testing
- PLAFOND diet
- Where
- 2 sites in United States
- Volunteers
- 120 people
- Sponsor
- University of California, Irvine
Chronic Kidney Disease
The Role of Vitamin D in Immune Function in Patients With Chronic Kidney Disease (CKD) Stages 3 and 4.
Patients with chronic kidney disease (CKD) are commonly deficient in vitamin D, with low levels of both calcidiol (25 hydroxy vitamin D) and calcitriol (1,25-hydroxy vitamin D).
- Trial name
- NCT00749736
- Testing
- cholecalciferol, doxercalciferol
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Indiana University
Healthy Volunteers, Chronic Kidney Disease
A Study of RBT-1 in Healthy Volunteers and Subjects With Stage 3/4 Chronic Kidney Disease
This is a Phase 1b, single-center, dose-escalating study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic effect of RBT-1 in healthy volunteers and in subjects with Stage 3/4 CKD.
- Trial name
- NCT03893799
- Testing
- RBT-1
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Renibus Therapeutics, 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
- 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.
Chronic Kidney Diseases
Skeletal Muscle Oxygenation in Patients With Chronic Kidney Disease Stage 2, 3 and 4
Endothelial dysfunction occurs early in chronic kidney disease (CKD) and is associated with target organ damage, progression of renal injury, cardiovascular events, and mortality.
- Trial name
- NCT05250167
- Where
- Greece
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Aristotle University Of Thessaloniki
Chronic Kidney Disease stage3, Chronic Kidney Disease stage4
Phase 3 Safety and Efficacy Study of CTAP101 Extended-release Capsules in Children With Secondary Hyperparathyroidism
This is a phase 3, multi-center, randomized, double-blind, placebo-controlled study in children with stage 3-4 chronic kidney disease (CKD), secondary hyperparathyroidism (SHPT) and vitamin D insufficiency.
- Conditions
- Chronic Kidney Disease stage3, Chronic Kidney Disease stage4, Vitamin d Deficiency, Secondary Hyperparathyroidism
- Trial name
- NCT05543928
- Testing
- CTAP101
- Where
- 2 sites in United States
- Volunteers
- 2 people
- Sponsor
- OPKO Health, Inc.
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)