Clinical trials: Non-dialysis Chronic Kidney Disease
Anaemia
Anemia Studies in CKD: Erythropoiesis Via a Novel PHI Daprodustat - Pediatric (ASCEND-P)
This is an international, multicenter trial, evaluating pharmacokinetics (PK) (4 weeks), safety (52 weeks), and hemoglobin (Hgb) response (52 weeks) to daprodustat in children and adolescent participants with anemia associated…
- Trial name
- ASCEND-P (NCT05682326)
- Testing
- Daprodustat
- Where
- 4 sites in Japan, South Korea
- Volunteers
- 4 people
- Sponsor
- GlaxoSmithKline
Secondary Hyperparathyroidism-Chronic Kidney Disease
Safety and Efficacy of Hectorol in Pediatric Patients With Chronic Kidney Disease Stage 3 and 4 With Secondary Hyperparathyroidism Not Yet on Dialysis
Primary Objective: Evaluated the effect of Hectorol® capsules in reducing elevated levels of intact parathyroid hormone (iPTH). Secondary Objectives: Evaluated the safety profile of Hectorol® capsules versus Rocaltrol®…
- Trial name
- NCT02859896
- Testing
- Doxercalciferol (GZ427397), Calcitriol
- Where
- 23 sites in United States, Chile
- Volunteers
- 21 people
- Sponsor
- Sanofi
The Aim of the Study Was to Screen Prevalence of Periodic Limb Movements Among Chronic Kidney Disease Patients
Periodic Limb Movements Among Dialysis and Non-dialysis Chronic Kidney Disease Patients
Periodic leg movement disorder is defined as periodic episodes of repetitive limb movements during sleep that mainly occur in the lower limb, including the hips, knees and toes and sometimes affects the upper limb.
- Trial name
- NCT05153616
- Testing
- Polysomnography
- Where
- Egypt
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Aswan University Hospital
Hyperphosphatemia, Kidney Disease
Fosrenol Post-marketing Surveillance in Japan
This study is a regulatory post-marketing surveillance in Japan and it is a local prospective and observational study of patients who have received Fosrenol.
- Trial name
- NCT01955876
- Testing
- Lanthanum Carbonate (Fosrenol, BAY77-1931)
- Where
- Japan
- Volunteers
- 343 people
- Sponsor
- Bayer
Anemia, Chronic Kidney Disease
Study to Assess Darbepoetin Alfa Dosing for the Correction of Anemia in Pediatric Patients With Chronic Kidney Disease
The primary objectives of this study are the following: 1. To test if the proportion of participants achieving a hemoglobin value greater than or equal to 10.0 g/dL at any time point after the first dose during the study is…
- Conditions
- Anemia, Chronic Kidney Disease, Kidney Disease
- Trial name
- NCT00436748
- Testing
- Darbepoetin Alfa
- Where
- 67 sites in United States, Belgium and 8 more
- Volunteers
- 116 people
- Sponsor
- Amgen
Chronic Kidney Disease, Not on Dialysis
Safety and Tolerability Study of MCI-196
The objective of this study is to assess the safety and tolerability of colestilan (MCI-196) in paediatric subjects (aged 2 years to <18 years) with CKD stages 3b to 5, diagnosed with hyperphosphataemia, who are not on dialysis.
- Conditions
- Chronic Kidney Disease, Not on Dialysis, Hyperphosphatemia, Paediatric
- Trial name
- NCT01818687
- Testing
- colestilan
- Where
- United Kingdom
- Volunteers
- 4 people
- Sponsor
- Tanabe Pharma Corporation
Chronic Kidney Disease
European Union Registry in Paediatric Chronic Kidney Disease Patients Looking at Safety and Usage Patterns of Darbepoetin Alfa
This European study observes paediatric patients with Chronic Kidney Disease using Darbepoetin Alfa to assess the drug's long term safety and profile the patterns of its use within this population.
- Trial name
- NCT00838097
- Volunteers
- 321 people
- Sponsor
- Amgen
Anemia, Renal Insufficiency, Chronic
Ascertain the Optimal Starting Dose of Mircera Given Subcutaneously for Maintenance Treatment of Anemia in Pediatric Patients With Chronic Kidney Disease on Dialysis or Not Yet on Dialysis.
Ascertain the starting dose of Mircera given subcutaneously for the maintenance treatment of anemia in pediatric participants with chronic kidney disease (CKD) on dialysis or not yet on dialysis when switching from stable…
- Trial name
- NCT03552393
- Testing
- Mircera
- Where
- 22 sites in United States, France and 5 more
- Volunteers
- 40 people
- Sponsor
- Hoffmann-La Roche
Pre-dialysis, End Stage Renal Disease
NESP Pediatric Study
Open-label, randomized study of NESP in pediatric subjects 18 years of age or younger. Subjects will receive study drug (NESP or rHuEPO) for 28 weeks after a 2 week screening and baseline period.
- Trial name
- NCT00527137
- Testing
- darbepoetin alfa, rHuEPO
- Volunteers
- 120 people
- Sponsor
- Amgen
Chronic Kidney Disease, Dialysis
Long-term Extension Study of MCI-196
The Primary Objectives of this study are to assess the long-term efficacy of treatment with colestilan (MCI-196) (including combination therapy) and to assess the long-term safety of treatment with colestilan (MCI-196) (including…
- Conditions
- Chronic Kidney Disease, Dialysis, Hyperphosphatemia, Paediatric
- Trial name
- NCT01814917
- Testing
- colestilan, CBPB
- Where
- United Kingdom
- Volunteers
- 6 people
- Sponsor
- Tanabe Pharma Corporation
Chronic Kidney Disease
Antibody Response to Human Papillomavirus Recombinant Vaccine (Gardasil®) in Girls and Young Women With Chronic Kidney Disease
People with chronic kidney disease are known to have immune response abnormalities, including a diminished response to some vaccinations.
- Trial name
- NCT00806676
- Testing
- Gardasil® Vaccine (FDA-approved vaccination regimen)
- Where
- 2 sites in United States
- Volunteers
- 67 people
- Sponsor
- Johns Hopkins University
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.
Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney Disease, Iron Deficiency Anaemia Due to Dietary Causes
The Role of Ferric Carboxymaltose in the Treatment of Pediatric Iron Deficiency Anemia in the Emergency Department
The goal of this project is to assess the feasibility, clinical effectiveness, and cost-effectiveness of IV iron therapy using ferric carboxymaltose (FCM) as a treatment for pediatric patients with iron deficiency anemia (IDA) in…
- Conditions
- Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney Disease, Iron Deficiency Anaemia Due to Dietary Causes, Iron Deficiency Anemia Treatment, Iron Deficiency Anemia Secondary to IBD or Gastric Bypass
- Trial name
- ED-Heme FCM (NCT07414199)
- Testing
- Ferric Carboxymaltose (FCM), Ferrous Sulfate
- Volunteers
- 150 people
- Sponsor
- Children's Hospital of Orange County
Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney Disease
Study to Evaluate the Safety and Tolerability of KRX-0502 (Ferric Citrate) in Children With Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney Disease
This study will be conducted to evaluate the safety and tolerability of ferric citrate in pediatric participants with iron deficiency anemia (IDA) associated with non-dialysis dependent chronic kidney disease (NDD-CKD).
- Trial name
- NCT04649411
- Testing
- ferric citrate, standard of care
- Sponsor
- Keryx Biopharmaceuticals
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.