Clinical trials: Chronic Nephropathy
Chronic Kidney Disease (CKD), Secondary Hyperparathyroidism (SHPT)
A Study to Evaluate Safety, Efficacy and Pharmacokinetics of Paricalcitol For Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Participants With Stage 5 Chronic Kidney Disease (CKD)
The main objective of this study is to evaluate the safety, efficacy and pharmacokinetics of paricalcitol oral solution in pediatric participants of ages 0 to 9 years with SHPT associated with stage 5 CKD receiving Peritoneal…
- Trial name
- NCT04064827
- Testing
- Paricalcitol
- Where
- 15 sites in United States, Puerto Rico
- Volunteers
- 2 people
- Sponsor
- AbbVie
Chronic Kidney Disease Requiring Chronic Dialysis, Hyperphosphatemia
Study to Evaluate the Use of Tenapanor as Core Therapy in the Treatment of Hyperphosphatemia
This is a randomized, open-label study to evaluate different methods of initiating tenapanor therapy in CKD patients on dialysis with hyperphosphatemia, when they are either phosphate binder naïve or on phosphate binder therapy.
- Trial name
- OPTIMIZE (NCT04549597)
- Testing
- Tenapanor
- Where
- United States
- Volunteers
- 333 people
- Sponsor
- Ardelyx
Hyperparathyroidism, Chronic Kidney Disease
Sevelamer and Secondary Hyperparathyroidism in Chronic Kidney Disease
The hypothesis underlying this study is that phosphate interferes with PTH-mediated calcium reabsorption in the distal nephron and thereby necessitates supranormal [PTH]to maintain normocalcemia in chronic kidney disease.
- Trial name
- NCT01191762
- Testing
- sevelamer carbonate
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Kenneth R. Phelps, M.D.
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
Anemia, Kidney Diseases
DELFT (Dynepo Evaluation of Long-Term Follow-Up Treatment)
This is a post-authorisation safety study to assess the incidence and severity of all pre-defined cardiovascular events in patients treated with DYNEPO, as well as to detect \& describe less common adverse drug reactions, and to…
- Conditions
- Anemia, Kidney Diseases, Renal Failure, Chronic, Kidney Failure, Chronic
- Trial name
- DELFT (NCT00664066)
- Testing
- DYNEPO (epoetin delta)
- Where
- 2 sites in Germany
- Volunteers
- 3 people
- Sponsor
- Shire
Hypertension
Systolic Blood Pressure Intervention Trial
Elevated blood pressure (BP) is an important public health concern. It is highly prevalent, the prevalence may be increasing, and it is a risk factor for several adverse health outcomes, especially coronary heart disease, stroke…
- Trial name
- SPRINT (NCT01206062)
- Testing
- Intensive control of SBP, Standard control of SBP
- Where
- United States
- Volunteers
- 9,361 people, healthy volunteers welcome
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
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, 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.
Renal Insufficiency, Chronic, Kidney Disease, Chronic
A Study of LY2928057 in Hemodialysis Participants
This study will evaluate the safety of LY2928057 and how LY2928057 affects hemoglobin in hemodialysis participants. This study will involve multiple doses of LY2928057 given during a 6 week period either after a participant…
- Trial name
- NCT01991483
- Testing
- LY2928057
- Where
- 4 sites in United States
- Volunteers
- 28 people
- Sponsor
- Eli Lilly and Company
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
Anemia, Iron Deficiency, Hyperphosphatemia
Ferric Citrate for the Prevention of Renal Failure in Adults With Advanced Chronic Kidney Disease
A 9-month randomized, double-blind, placebo-controlled study to compare the effect of fixed dose ferric citrate versus placebo in patients with advanced chronic kidney disease (eGFR ≤20 ml/min/1.73m2) on the composite endpoint of…
- Conditions
- Anemia, Iron Deficiency, Hyperphosphatemia, Renal Insufficiency, Chronic, Renal Anemia
- Trial name
- FRONTIER (NCT05085275)
- Testing
- Ferric Citrate 1 GM Oral Tablet [AURYXIA]
- Where
- 23 sites in United States
- Volunteers
- 289 people
- Sponsor
- USRC Kidney Research
Anemia in Chronic Kidney Disease in Non-dialysis Patients
Roxadustat in the Treatment of Anemia in Chronic Kidney Disease (CKD) Patients, Not on Dialysis, in Comparison to Darbepoetin Alfa
The primary objective of this study was to evaluate the efficacy of roxadustat compared to darbepoetin alfa in the treatment of anemia in nondialysis-dependent chronic kidney disease (NDD CKD) participants.
- Trial name
- Dolomites (NCT02021318)
- Testing
- Roxadustat, Darbepoetin alfa
- Where
- 125 sites in Austria, Belarus and 24 more
- Volunteers
- 616 people
- Sponsor
- Astellas Pharma Europe B.V.
End-stage Renal Disease
Provision of Antioxidant Therapy in Hemodialysis (PATH) Study
Studies have shown that end stage renal disease (ESRD) patients have higher levels of blood markers which their body makes in response to increased stress and injury.
- Trial name
- NCT00237718
- Testing
- Alpha, gamma, beta, and delta (mixed) tocopherols, Alpha lipoic acid
- Where
- United States
- Volunteers
- 385 people
- Sponsor
- Vanderbilt University
HIV/AIDS, ESRD
Pharmacokinetics of JULUCA in Hemodialysis
This study will compare the pharmacokinetics of the component drugs in JULUCA, and HIV combination treatment pill, in HIV-negative patients who require hemodialysis with those with normal renal function.
- Trial name
- NCT04431518
- Testing
- JULUCA 50Mg-25Mg Tablet
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Indiana University
Hyperparathyroidism, Secondary
Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease on Hemodialysis
This study is designed to assess the efficacy and safety of etelcalcetide compared with placebo in the treatment of SHPT in patients with chronic kidney disease (CKD) receiving hemodialysis.
- Trial name
- NCT01785849
- Testing
- Etelcalcetide
- Where
- 118 sites in United States, Australia and 13 more
- Volunteers
- 508 people
- Sponsor
- Amgen
Anaemia
A Study to Evaluate Efficacy and Safety of Daprodustat Compared to Darbepoetin Alfa in Japanese Hemodialysis (HD)-Dependent Subjects With Anemia Associated With Chronic Kidney Disease (CKD)
Daprodustat is a drug that is currently being developed as a treatment for renal anemia . This study is to evaluate the efficacy and safety of daprodustat following a switch from erythropoiesis-stimulating agent (ESA) in Japanese…
- Trial name
- NCT02969655
- Testing
- Daprodustat small, Daprodustat large, Darbepoetin alfa
- Where
- 50 sites in Japan
- Volunteers
- 271 people
- Sponsor
- GlaxoSmithKline
Kidney Failure, Chronic, End-Stage Renal Disease
Comparison of Nocturnal Hemodialysis (NHD) and Short Daily Hemodialysis (DHD) With the NxStage® System One™
The purpose of this study is to determine whether or not nocturnal hemodialysis is equivalent to short daily hemodialysis on a per treatment basis, using the NxStage System One in the home setting.
- Trial name
- NCT00667511
- Testing
- NxStage System One
- Where
- 9 sites in United States
- Volunteers
- 58 people
- Sponsor
- NxStage Medical
Renal Disease, End Stage, Kidney Disease, End-Stage
Ellipsys Vascular Access System Post Market Surveillance (PS) Study
The proposed clinical study is a prospective, non-randomized, multi-center, single-arm, observational, post-market surveillance (PS) study of the Ellipsys Vascular Access System in subjects eligible for arteriovenous (AV) fistula.
- Conditions
- Renal Disease, End Stage, Kidney Disease, End-Stage, AV Fistula, Fistulas Arteriovenous
- Trial name
- NCT04484220
- Testing
- Ellipsys Vascular Access System
- Where
- 12 sites in United States
- Volunteers
- 142 people
- Sponsor
- Medtronic Endovascular
Kidney Failure
Everolimus Plus Mycophenolic Acid for Kidney Preservation in Liver Transplant Recipients With Impaired Kidney Function
Tacrolimus is the standard immunosuppressive drug used to prevent organ rejection post liver transplant. One side effect of Tacrolimus is nephrotoxicity. Everolimus does not have the nephrotoxicity side effects of Tacrolimus.
- Trial name
- NCT04258423
- Testing
- Tacrolimus, Everolimus
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Indiana University
Chronic Kidney Disease, End Stage Renal Failure on Dialysis
Safety and Efficacy Study of BCD-066 Compared to Aranesp® for Anemia Treatment in Chronic Kidney Disease Patients
The purpose of the study is to prove equivalence of efficacy and safety of BCD-066 and Aranesp® in treatment of anemia in end-stage chronic kidney disease patients on dialysis.
- Conditions
- Chronic Kidney Disease, End Stage Renal Failure on Dialysis, Anemia
- Trial name
- NCT02506868
- Testing
- Darbepoetin alfa
- Where
- 30 sites in Russia
- Volunteers
- 196 people
- Sponsor
- Biocad