Clinical trials: Chronic Kidney Insufficiency
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
Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic
Sitagliptin Versus Glipizide in Participants With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency (MK-0431-063 AM1)
The purpose of the study is to compare how sitagliptin and glipizide lower blood glucose levels in participants with moderate or severe renal insufficiency.
- Trial name
- NCT00509262
- Testing
- Sitagliptin, Glipizide
- Volunteers
- 426 people
- Sponsor
- Merck Sharp & Dohme LLC
Chronic Kidney Failure
Efficacy and Safety Study of Magnesium Iron Hydroxycarbonate for the Reduction of High Blood Phosphate in Hemodialysis Patients
Magnesium iron hydroxycarbonate is a phosphate binder that absorbs phosphate from food, reducing the amount that the body can absorb.
- Trial name
- NCT00317694
- Testing
- Fermagate
- Where
- 15 sites in United States, United Kingdom
- Volunteers
- 111 people
- Sponsor
- Ineos Healthcare Limited
Chronic Kidney Disease, Hyperparathyroidism, Secondary
Study to Evaluate Cinacalcet in Children With Chronic Kidney Disease
The primary objective of the study was to evaluate the safety and tolerability of cinacalcet after a single oral dose in children aged 28 days to less than 6 years with chronic kidney disease receiving dialysis.
- Conditions
- Chronic Kidney Disease, Hyperparathyroidism, Secondary, Secondary Hyperparathyroidism
- Trial name
- NCT01290029
- Testing
- Cinacalcet
- Where
- 10 sites in United States, Germany and 1 more
- Volunteers
- 14 people
- Sponsor
- Amgen
End Stage Renal Disease, End Stage Renal Failure on Dialysis
First-in-Human (FIH) Study of the Xeltis Hemodialysis Access Graft
A feasibility study is to assess the preliminary safety and performance of the Xeltis hemodialysis access (aXess) graft.
- Trial name
- aXess-FIH (NCT04898153)
- Testing
- aXess
- Where
- 6 sites in Belgium, Italy and 2 more
- Volunteers
- 20 people
- Sponsor
- Xeltis
Type 2 Diabetes Mellitus, Chronic Kidney Disease
A Study Called SMART-Finder to Look for People With Increased Amounts of Albumin in the Urine (UACR Level) in a Group of Type 2 Diabetes Mellitus Patients
This is an observational study in which data from people with type 2 diabetes mellitus (T2DM) in Germany who use the medical app "myTherapy" are studied.
- Trial name
- SMART-Finder (NCT05552339)
- Testing
- Finerenone (Kerendia, BAY94-8862), Type 2 DM drugs
- Where
- Germany
- Volunteers
- 348 people
- Sponsor
- Bayer
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
Hyperphosphatemia Related to Chronic Kidney Disease
Study to Evaluate the Safety and Tolerability of Ferric Citrate in Children With Hyperphosphatemia Related to Chronic Kidney Disease
This study will be conducted to assess the safety and tolerability of ferric citrate in pediatric participants with hyperphosphatemia related to chronic kidney disease (CKD).
- Trial name
- NCT04523727
- Testing
- ferric citrate
- Where
- 14 sites in United States
- Volunteers
- 45 people
- Sponsor
- Keryx Biopharmaceuticals
Chronic Kidney Disease
Observational Study on CKD Treatment With a Ketosteril Supplemented Protein-restricted Diet (Keto-024-CNI)
The purpose of this study is to characterize the patient and disease profile under the influence of a protein-restricted diet supplemented with keto acids/amino acids (KA/AA), focusing on the progression of chronic renal…
- Trial name
- NCT02756520
- Testing
- Observational study: Supplemented protein-restricted diet
- Where
- China
- Volunteers
- 154 people
- Sponsor
- Fresenius Kabi
Chronic Kidney Disease, Secondary Hyperparathyroidism
Quality of Life in Greek Hemodialysis Patients Receiving Zemplar Intravenous
The purpose of this study is to assess health-related Quality of Life (QoL) changes in participants with chronic kidney disease (CKD) and secondary hyperparathyroidism (sHPT) undergoing hemodialysis and receiving paricalcitol…
- Trial name
- QUALITIZE (NCT01368042)
- Where
- 11 sites in Greece
- Volunteers
- 265 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
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.
Healthy
Effect of Renal Impairment on the Pharmacokinetics, and Safety of Megestrol Acetate Concentrated Suspension
To determine the pharmacokinetics and safety of megestrol acetate after a single oral 300 mg dose of megestrol acetate concentrated suspension in healthy subjects, and subjects with varying degrees of renal impairment
- Trial name
- NCT00637403
- Testing
- Megestrol acetate concentrated suspension 125 mg/mL
- Where
- United States
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Par Pharmaceutical, Inc.
End Stage Renal Disease
Adenovirus Vascular Endothelial Growth Factor (VEGF) Therapy in Vascular Access - Novel Trinam AGainst Control Evidence
Patients in renal failure on hemodialysis depend on adequate and sustained vascular access. This can be achieved by surgical placement of a synthetic polytetrafluoroethylene (PTFE) graft.
- Trial name
- AdV-VANTAGE (NCT00895479)
- Testing
- Graft placement surgery plus Trinam therapy
- Where
- 12 sites in United States
- Volunteers
- 250 people
- Sponsor
- Ark Therapeutics Ltd
Type 2 Diabetes
Effect of Retatrutide Compared With Placebo in Participants With Type 2 Diabetes and Moderate or Severe Renal Impairment, With Inadequate Glycemic Control on Basal Insulin, With or Without Metformin and/or SGLT2 Inhibitor (TRANSCEND-T2D-3)
The purpose of this study is to investigate the efficacy and safety of retatrutide compared with placebo in participants with Type 2 Diabetes and renal impairment, with inadequate glycemic control on basal insulin alone or a…
- Trial name
- NCT06297603
- Testing
- Retatrutide
- Where
- 76 sites in United States, Argentina and 5 more
- Volunteers
- 320 people
- Sponsor
- Eli Lilly and Company
Hyperphosphataemia, ESRD
Non-interventional Study to Evaluate the Ease of Reaching Individual Goals in Serum Phosphorus (Steering)
The objective of this non-interventional study is to confirm that with standard OsvaRen® treatment it is possible to achieve in at least 60% of the patients the levels of phosphorus, total calcium, and iPTH seen in the CALMAG…
- Trial name
- Steering (NCT01424787)
- Where
- 24 sites in Denmark, Germany and 2 more
- Volunteers
- 324 people
- Sponsor
- Fresenius Medical Care Deutschland GmbH
Chronic Kidney Disease (CKD)
Study of the Safety, Tolerability, and Pharmacokinetics of LHW090 in Patients With Moderately Impaired Renal Function
This was a randomized, double-blind, parallel group, placebo-controlled study, in two sequential parts that evaluated the renal safety, tolerability and pharmacokinetics of LHW090 in patients with moderately impaired renal…
- Trial name
- LHW090 (NCT02678000)
- Testing
- LHW090
- Where
- 12 sites in United States, Germany
- Volunteers
- 84 people
- Sponsor
- Novartis Pharmaceuticals
End Stage Renal Disease, Inflammation
Inflammation and Nutritional Parameters in Hemodialysis Patients Using Reprocessed Dialyzers
The study is a prospective cohort trial utilizing sequential laboratory results from excess serum obtained from hemodialysis patients (acting as their own controls).
- Trial name
- NCT00440908
- Where
- 2 sites in United States
- Volunteers
- 2,500 people
- Sponsor
- Fresenius Medical Care North America
Anaemia
4 Week Correction Study in Subjects With Anemia Associated With Chronic Kidney Disease Who Are Not Undergoing Dialysis
This is a four-week Phase IIa, randomized, double-blind, placebo-controlled, parallel-group, multi-center study to evaluate the safety, efficacy and pharmacokinetics of GSK1278863 in approximately 68 subjects with anemia…
- Trial name
- NCT01587898
- Testing
- GSK1278863
- Where
- 55 sites in United States, Canada and 1 more
- Volunteers
- 72 people
- Sponsor
- GlaxoSmithKline
Chronic Kidney Disease
Optimal Titration Regimen for SBR759 in Lowering Serum Phosphate Levels in Asian Chronic Kidney Disease Patients on Hemodialysis
This study will determine the titration regimen for SBR759 compared to sevelamer HCl in lowering serum phosphate levels in Asian Chronic Kidney Disease patients on hemodialysis
- Trial name
- SBR759 (NCT00704678)
- Testing
- SBR759, Sevelamer HCl
- Where
- 15 sites in Japan, Taiwan
- Volunteers
- 203 people
- Sponsor
- Novartis Pharmaceuticals
End-stage Renal Disease (ESRD)
A Study of Safety, PK, & PD of ISIS 416858 Administered Subcutaneously to Patients With End-Stage Renal Disease on Hemodialysis
Evaluation of safety, tolerability, PK and PD of ISIS 416858 in patients with end-stage renal disease (ESRD) receiving chronic hemodialysis.
- Trial name
- NCT02553889
- Testing
- ISIS 416858
- Where
- 8 sites in Canada
- Volunteers
- 49 people
- Sponsor
- Ionis Pharmaceuticals, Inc.