Clinical trials: Non-Dialysis-Dependent Chronic Kidney Disease
Anemia, Non-Dialysis-Dependent Chronic Kidney Disease
Study to Evaluate Vadadustat for the Correction of Anemia in Participants With Non-dialysis-dependent Chronic Kidney Disease
A multicenter, randomized, open-label, active-controlled Phase 3 study for the correction of anemia and maintenance of hemoglobin (Hb) in participants with Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD)
- Trial name
- NCT02648347
- Testing
- Vadadustat, Darbepoetin alfa
- Where
- 439 sites in United States, Argentina and 18 more
- Volunteers
- 1,751 people
- Sponsor
- Akebia Therapeutics
Iron Deficiency Anaemia, Iron Deficiency Anemia
Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose for Treatment of Iron Deficiency Anemia in Non-Dialysis-Dependent Chronic Kidney Disease
Evaluation of safety and efficacy of iron isomaltoside/ferric derisomaltose compared with iron sucrose, in subjects with both non-dialysis-dependent chronic kidney disease (NDD-CKD) and iron deficiency anaemia (IDA).
- Conditions
- Iron Deficiency Anaemia, Iron Deficiency Anemia, Chronic Kidney Disease
- Trial name
- NCT02940860
- Testing
- Iron isomaltoside/ferric derisomaltose, Iron sucrose
- Where
- 141 sites in United States
- Volunteers
- 1,538 people
- Sponsor
- Pharmacosmos A/S
Anemia, Non-Dialysis-Dependent Chronic Kidney Disease
Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Participants With Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD)
A multicenter, randomized, open-label, active-controlled Phase 3 study for the maintenance treatment of anemia in participants with Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD)
- Trial name
- NCT02680574
- Testing
- Vadadustat, Darbepoetin alfa
- Where
- 503 sites in United States, Argentina and 28 more
- Volunteers
- 1,725 people
- Sponsor
- Akebia Therapeutics
Anemia of Chronic Kidney Disease
A Pilot Study of KRX-0502 (Ferric Citrate, Administered Without Food, in Treating Iron-deficiency Anemia
The objective of the study is to evaluate the efficacy and safety of KRX-0502, administered without food, in treating iron deficiency anemia in subjects with stage 3 to 5 non-dialysis dependent chronic kidney disease (NDD-CKD).
- Trial name
- NCT02128074
- Testing
- KRX-0502
- Where
- 3 sites in Israel
- Volunteers
- 32 people
- Sponsor
- Keryx Biopharmaceuticals
Anemia; Non-dialysis Dependent Chronic Kidney Disease
Efficacy and Safety Study to Evaluate MT-6548 in Non-dialysis Subjects With Anemia Associated With Chronic Kidney Disease in Japan
For Non-dialysis subjects with anemia associated with chronic kidney disease, demonstrate non-inferiority of MT-6548 compared to darbepoetin alfa using Hb value and evaluate long-term safety of MT-6548.
- Trial name
- NCT03329196
- Testing
- MT-6548, Darbepoetin alfa
- Where
- 31 sites in Japan
- Volunteers
- 304 people
- Sponsor
- Tanabe Pharma Corporation
Iron Deficiency Anaemia, Chronic Kidney Disease
Ferric Carboxymaltose (FCM) Assessment in Subjects With Iron Deficiency Anaemia and Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD)
Phase IIIb study to evaluate the long-term efficacy of ferric carboxymaltose (FCM) (using targeted ferritin levels to determine dosing) or oral iron in non-dialysis-dependent chronic kidney disease (NDD-CKD) subjects with iron…
- Trial name
- FIND-CKD (NCT00994318)
- Testing
- FCM (Ferric carboxymaltose) high ferritin target, FCM (Ferric carboxymaltose) low ferritin target, Oral Iron (Ferrous sulphate)
- Where
- 19 sites in United States, Australia and 17 more
- Volunteers
- 626 people
- Sponsor
- Vifor Pharma
Chronic Kidney Diseases, Iron Deficiency Anemia
KRX-0502 (Ferric Citrate) in Subjects With NDD-CKD and IDA (The COMPASS Trial)
The objectives of this study are to assess the long-term efficacy and safety of different dose regimens of KRX-0502 in the treatment of iron deficiency anemia (IDA) in adult subjects with non-dialysis dependent chronic kidney…
- Trial name
- COMPASS (NCT03236246)
- Testing
- KRX-0502
- Where
- 28 sites in United States
- Volunteers
- 206 people
- Sponsor
- Keryx Biopharmaceuticals
End-stage Kidney Disease, Kidney Disease, Chronic
Safety, Tolerability, and Feasibility of Empagliflozin Therapy in Dialysis-dependent ESKD
The purpose of this study is to find out if empagliflozin, a new diabetic medication that has been shown to be very effective in lowering the risk of heart failure, is safe and tolerated in dialysis patients.
- Conditions
- End-stage Kidney Disease, Kidney Disease, Chronic, Dialysis, Diabetic
- Trial name
- NCT05614115
- Testing
- Empagliflozin
- Where
- United States
- Volunteers
- 62 people
- Sponsor
- University of Utah
Anemia
VIT45 Versus Oral Iron in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease
This study compares the efficacy and safety of intravenous (IV) iron (VIT45) versus oral iron (ferrous sulfate) administered to subjects who suffer from anemia and are diagnosed with non-dialysis dependent chronic kidney disease…
- Trial name
- NCT00317239
- Testing
- Ferrous Sulfate tablets, Ferric Carboxymaltose (FCM)
- Where
- United States
- Volunteers
- 255 people
- Sponsor
- American Regent, Inc.
Anaemia
Anemia Study in Chronic Kidney Disease (CKD) : Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat -Forearm Blood Flow (ASCEND-FBF)
Daprodustat has demonstrated an ability to effectively raise hemoglobin concentrations with lower erythropoietin (EPO) levels than those observed after administration of recombinant human erythropoietin (rhEPOs).
- Trial name
- NCT03446612
- Testing
- Daprodustat, Darbepoetin alfa, Acetylcholine
- Where
- 3 sites in United Kingdom
- Volunteers
- 6 people
- Sponsor
- GlaxoSmithKline
Iron Deficiency Anemia, Chronic Kidney Disease
Iron Isomaltoside 1000 (Monofer®) in Non-Dialysis Dependent Chronic Kidney Disease and With Renal-Related Anaemia
The study is designed to determine the effects of an investigational drug Monofer in subjects with non-dialysis dependent chronic kidney disease (NDD-CKD) subjects and with iron deficiency anaemia (IDA).
- Trial name
- NCT01102413
- Testing
- Monofer, Iron Sulphate
- Where
- Denmark
- Volunteers
- 351 people
- Sponsor
- Pharmacosmos A/S
Anaemia
A Study to Evaluate Safety and Efficacy of GSK1278863 in Non-Dialysis Dependent (NDD) Subjects With Anemia Associated With Chronic Kidney Diseases (CKD)
This study will be conducted in approximately 228 subjects with anemia associated with CKD who are not on dialysis. Two groups of subjects will be enrolled into the study: Group 1: recombinant human erythropoietin (rhEPO) naive…
- Trial name
- NCT01977573
- Testing
- GSK1278863, rhEPO
- Where
- 123 sites in United States, Australia and 13 more
- Volunteers
- 252 people
- Sponsor
- GlaxoSmithKline
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
Anemia, Non-dialysis Dependent Chronic Kidney Disease
Dose-Finding Study of Vadadustat in Japanese Subjects With Anemia Secondary to Non-Dialysis Dependent Chronic Kidney Disease (NDD-CKD)
This is a Phase 2, randomized, double-blind, placebo-controlled, dose-finding study to assess the efficacy, safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) of orally administered vadadustat in Japanese…
- Trial name
- NCT03054337
- Testing
- Vadadustat
- Where
- 18 sites in Japan
- Volunteers
- 51 people
- Sponsor
- Akebia Therapeutics
Anemia
Long Term Safety Study of (VIT45) Extension Study: Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease
The primary objective of this study is to evaluate the long term safety and tolerability of an iron maintenance dosing strategy utilizing VIT45 in the treatment of anemia of non-dialysis dependent chronic kidney disease…
- Trial name
- NCT00317226
- Testing
- Ferric Carboxymaltose (FCM)
- Where
- United States
- Volunteers
- 145 people
- Sponsor
- American Regent, Inc.