Clinical trials: CKD Stage 3
IgA Nephropathy
Study of the Safety and Efficacy of OMS721 in Patients With Immunoglobulin A (IgA) Nephropathy
The primary objective of this study is to evaluate the effect of OMS721 on 24-hour urine protein excretion (UPE) in IgA nephropathy (IgAN) patients with high baseline proteinuria (high-risk proteinuria group; 24-hour UPE ≥ 2…
- Trial name
- NCT03608033
- Testing
- OMS721, Vehicle (D5W or saline)
- Where
- 139 sites in United States, Argentina and 21 more
- Volunteers
- 360 people
- Sponsor
- Omeros Corporation
Chronic Kidney Disease Requiring Chronic Dialysis
A Phase 3 Extension Study to Investigate the Long-term Safety, Tolerability and Efficacy of PA21, a Phosphate Binder in Dialysis Patients
This is a Phase 3, randomised, active controlled, multicentre extension study to investigate the long-term safety and efficacy of PA21, a phosphate binder, for control of hyperphosphataemia in dialysis patients.
- Trial name
- NCT01464190
- Testing
- PA21 (2.5 g tablet containing 500 mg iron), Sevelamer carbonate
- Where
- 15 sites in United States, Austria and 13 more
- Volunteers
- 659 people
- Sponsor
- Vifor Pharma
Anaemia, Aspergillosis, Allergic Bronchopulmonary
Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Dialysis (ASCEND-D)
The purpose of this multi-center event-driven study in participants with anemia associated with chronic kidney disease (CKD) to evaluate the safety and efficacy of daprodustat.
- Trial name
- NCT02879305
- Testing
- Daprodustat, rhEPO, Iron therapy
- Where
- 462 sites in United States, Argentina and 33 more
- Volunteers
- 2,964 people
- Sponsor
- GlaxoSmithKline
Chronic Kidney Disease, Dialysis
A Phase 3, Randomized, Double Blind, Placebo-Controlled, Multi-Center, Withdrawal Study of MCI-196 in CKD on Dialysis With Hyperphosphatemia
This is a phase III multi-centre study in three periods: the first period is a phosphate binder washout for 4 weeks, the second period is an open-label, flexible dose titration, the third period is a placebo-controlled withdrawal…
- Conditions
- Chronic Kidney Disease, Dialysis, Hyperphosphatemia
- Trial name
- NCT00506441
- Testing
- MCI-196
- Where
- 39 sites in United States, Puerto Rico
- Volunteers
- 245 people
- Sponsor
- Tanabe Pharma Corporation
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, 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)
Anemia
An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Stage III-IV Chronic Kidney Disease Patients Not on Dialysis With Renal Anemia
This observational study will evaluate the use in clinical practice and efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in stage III-IV chronic kidney disease patients not on dialysis receiving Mircera for the…
- Trial name
- NCT01695746
- Testing
- C.E.R.A.
- Where
- 6 sites in India
- Volunteers
- 108 people
- Sponsor
- Hoffmann-La Roche
Anemia, Kidney Disease
42-Day Repeat Oral Dose Study of AKB-6548 in Participants With Chronic Kidney Disease and Anemia
The purpose of this study is to evaluate the dose response (efficacy), pharmacodynamic response, pharmacokinetics, safety, and tolerability of orally administered AKB-6548 in pre-dialysis participants with anemia with repeat…
- Trial name
- NCT01381094
- Testing
- AKB-6548
- Where
- 28 sites in United States
- Volunteers
- 93 people
- Sponsor
- Akebia Therapeutics
Chronic Kidney Disease Stage 3 and 4
Vitamin D Supplement Study for Stage Three and Four Chronic Kidney Disease (CKD) Patients
The purpose of this study is to examine the effectiveness of vitamin D3 versus vitamin D2 in raising vitamin D levels and suppressing parathyroid hormone levels in patients with kidney disease who are not on dialysis.
- Trial name
- UPGRADE (NCT01173848)
- Testing
- Ergocalciferol, Cholecalciferol
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- The Cleveland Clinic
Metabolic Acidosis
Evaluation of TRC101 in Subjects With Metabolic Acidosis Associated With Chronic Kidney Disease
This is a multicenter, double-blind, placebo-controlled, parallel-design study. The study will enroll approximately 210 adult male and female subjects with stage 3 or 4 chronic kidney disease and metabolic acidosis.
- Trial name
- NCT03317444
- Testing
- TRC101
- Where
- 44 sites in United States, Bulgaria and 6 more
- Volunteers
- 217 people
- Sponsor
- Tricida, Inc.
Anemia
Safety and Efficacy Study of Roxadustat to Treat Anemia in Patients With Chronic Kidney Disease, on Dialysis.
The purpose of this study is to evaluate the efficacy and safety of roxadustat compared to epoetin alfa for the treatment of anemia in chronic kidney disease patients on dialysis.
- Trial name
- NCT02174731
- Testing
- Roxadustat, Epoetin alfa
- Where
- 188 sites in United States, Australia and 16 more
- Volunteers
- 2,133 people
- Sponsor
- AstraZeneca
Osteoporosis, Chronic Kidney Disease
Denosumab for Prevention of Osteoporosis in Renal Transplant Recipients
The primary objective of the study is to examine the effect of denosumab on lumbar spine bone mineral density (BMD) after one year of treatment in newly transplanted renal allograft recipients.
- Trial name
- POSTOP (NCT01377467)
- Testing
- Denosumab (Prolia)
- Where
- Switzerland
- Volunteers
- 90 people
- Sponsor
- Rudolf Wuethrich
Secondary Hyperparathyroidism, Chronic Kidney Disease
Paricalcitol Versus Calcitriol for Efficacy and Safety in Stage 3/4 Chronic Kidney Disease (CKD) With Secondary Hyperparathyroidism (SHPT)
Secondary Hyperparathyroidism (SHPT) occurs in many patients with kidney disease and leads to bone disease. Active forms of vitamin D, calcitriol and paricalcitol, treat SHPT, but may have different effects on blood calcium.
- Trial name
- PACE (NCT00823303)
- Testing
- Paricalcitol, Calcitriol
- Where
- 4 sites in United States
- Volunteers
- 110 people
- Sponsor
- Washington University School of Medicine
Healthy Volunteers (Intended Indication: Chronic Kidney Disease)
A Study to Assess the Effect of Verinurad on the Electric Activity of the Heart
This study will be conducted to investigate the safety of verinurad in healthy volunteers in combination with allopurinol 300 mg, compared with placebo in particular its effect on electrocardiogram (ECG), with focus on the QT/QTc…
- Trial name
- NCT04256629
- Testing
- Verinurad, Allopurinol
- Where
- Germany
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Anemia
A Study of MIRCERA in Participants With Chronic Kidney Disease Stage 3-4 and Not on Dialysis
An observational, longitudinal, multi-center, non-interventional study in participants with chronic kidney disease (CKD) stage 3-4, assessed by Modification of Diet in Renal Disease (MDRD) to collect data regarding safety and…
- Trial name
- NCT02567188
- Testing
- MIRCERA
- Where
- 20 sites in Sweden
- Volunteers
- 144 people
- Sponsor
- Hoffmann-La Roche
Healthy Volunteers, Chronic Kidney Disease
A Study of RBT-9 in Healthy Volunteers and Volunteers 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-9 in healthy volunteers and in subjects with Stage 3/4 CKD.
- Trial name
- NCT04072861
- Testing
- RBT-9
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Renibus Therapeutics, Inc.
Complication of Renal Dialysis, End Stage Renal Disease
Trial to Evaluate the Sirolimus-Eluting Collagen Implant on AV Fistula Outcomes
The objective of this study is to evaluate efficacy and safety outcomes following use of the Sirolimus-eluting Collagen Implant (SeCI) in subjects undergoing surgical creation of an AV fistula for vascular access (index…
- Conditions
- Complication of Renal Dialysis, End Stage Renal Disease, End Stage Kidney Disease, ESRD
- Trial name
- ACCESS (NCT02513303)
- Testing
- Sirolimus, AV Fistula Surgery, Sirolimus-eluting Collagen Implant (SeCI)
- Where
- 4 sites in United States
- Volunteers
- 269 people
- Sponsor
- Vascular Therapies, Inc.
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.
Type 2 Diabetes Mellitus, Chronic Kidney Disease Stage 3
Safety and Efficacy Study of Sotagliflozin on Glucose Control in Participants With Type 2 Diabetes, Moderate Impairment of Kidney Function, and Inadequate Blood Sugar Control
Primary Objective: To demonstrate the superiority of Sotagliflozin 200 milligrams (mg) and Sotagliflozin 400 mg versus placebo on HbA1c reduction at 26 Weeks in participants with Type 2 diabetes who have inadequate glycemic…
- Trial name
- SOTA-CKD3 (NCT03242252)
- Testing
- Sotagliflozin
- Where
- 170 sites in United States, Argentina and 14 more
- Volunteers
- 787 people
- Sponsor
- Lexicon Pharmaceuticals
Hepatitis C, Chronic Kidney Disease
Effect of Harvoni on Proteinuria and eGFR in Hepatitis C Virus Associated Chronic Kidney Disease (CKD)
Treatment protocol to see if people with hepatitis C (HCV) and chronic kidney disease (CKD) who are treated with Harvoni for 12 weeks have improvements in their kidney disease.
- Trial name
- NCT02503735
- Testing
- Sofosbuvir/Ledipasvir FDC
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Massachusetts General Hospital