Clinical trials: Hyperparathyroidism; Secondary, Renal
Hemodialysis Complication, Shoulder Joint Disorder
The Effect of Baduanjin on Shoulder Function in Maintenance Hemodialysis Patients
The aim of this study is to examine the effect of 18-month Baduanjin exercise on shoulder joint function in maintenance hemodialysis (MHD) patients.
- Conditions
- Hemodialysis Complication, Shoulder Joint Disorder, CKD-MBD
- Trial name
- NCT06314321
- Testing
- Baduanjin exercise
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Affiliated Hospital of Nantong University
Chronic Kidney Disease Mineral and Bone Disorder, Renal Osteodystrophy
The Effect of Etelcalcetide on CKD-MBD
The proposed study will investigate the effects of etelcalcetide on the bone and blood-vessel health in patients with CKD-MBD. The investigators will test if etelcalcetide makes bone and blood-vessels healthier.
- Conditions
- Chronic Kidney Disease Mineral and Bone Disorder, Renal Osteodystrophy, Vascular Calcification, Hyperparathyroidism; Secondary, Renal
- Trial name
- Parsabiv-MBD (NCT03960437)
- Testing
- Etelcalcetide
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Thomas Nickolas, MD MS
Chronic Kidney Disease
RAYALDEE Non Interventional Study (NIS) on Effectiveness in ND-CKD SHPT Patients
The overall study objective is to collect real-world data on the safety and effectiveness of ERC to gradually increase 25D to the level required by Stage 3 and 4 CKD patients.
- Trial name
- PORTRAY (NCT05460234)
- Where
- 16 sites in Germany
- Volunteers
- 110 people
- Sponsor
- Vifor (International) Inc.
Osteoporosis, Renal Osteodystrophy
The Effects of 12-months of Denosumab on Bone Density in Prevalent Kidney Transplant Recipients
This is a Phase 2 Multi-Center Clinical Trial (safety and effectiveness trial) in 60 patients (40 denosumab; 20 placebo) who have had a kidney transplant for 12-months or longer with more than 30% of kidney function.
- Conditions
- Osteoporosis, Renal Osteodystrophy, Kidney Transplant; Complications
- Trial name
- ProliaKTx (NCT03960554)
- Testing
- Denosumab Inj 60 mg/ml
- Where
- 3 sites in United States
- Volunteers
- 8 people
- Sponsor
- Thomas Nickolas, MD MS
Secondary Hyperparathyroidism, Renal Failure
Study of Safety and Efficacy of Doxercalciferol in Patients With Chronic Kidney Disease, Stage 3 or 4, and Secondary Hyperparathyroidism
The purpose of this study is to demonstrate the safety and effectiveness of Hectorol® (doxercalciferol) capsules in treating patients with Stage 3 or Stage 4 chronic kidney disease (CKD) with secondary hyperparathyroidism who…
- Conditions
- Secondary Hyperparathyroidism, Renal Failure, Chronic Renal Insufficiency
- Trial name
- NCT00123461
- Testing
- Hectorol (doxercalciferol capsules), 0.5mcg
- Where
- 19 sites in United States, Puerto Rico
- Volunteers
- 70 people
- Sponsor
- Genzyme, a Sanofi Company
Chronic Kidney Disease, Renal Osteodystrophy
Serum Sclerostin Levels, Cardiovascular Parameters and Carpal Tunnel Syndrome in Maintenance Hemodialysis Patients
Sclerostin, the product of the SOST gene, located on chromosome 17, locus q11.2 in humans, was originally believed to be a non-classical Bone morphogenetic protein (BMP) antagonist.Sclerostin was recently identified as a…
- Conditions
- Chronic Kidney Disease, Renal Osteodystrophy, Left Ventricular Hypertrophy
- Trial name
- NCT01382966
- Where
- Turkey (Türkiye)
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- RFM Renal Treatment Services
Secondary Hyperparathyroidism, End Stage Renal Disease
A Study to Follow-up Patients With End Stage Renal Disease Undergoing Hemodialysis, Receiving Selective Vitamin D Receptor Activator's for Prevention and Treatment of Secondary Hyperparathyroidism
The aim of this post-marketing observational study is to obtain further data on the long term use, safety and efficacy of selective Vitamin D Receptor Activator's as it is prescribed in the normal clinical setting and according…
- Trial name
- NCT01149291
- Where
- 22 sites in Turkey (Türkiye)
- Volunteers
- 511 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Secondary Hyperparathyroidism
FGF-23 (Fibroblast Growth Factor 23) Regulation in Chronic Kidney Disease
FGF-23 is a newly described protein that is an important regulator of phosphorus in the body. This protein increases in people with kidney disease and people who need dialysis have very high levels of FGF-23 in the blood.
- Trial name
- NCT00999037
- Testing
- Sevelamer Carbonate
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- University of California, Los Angeles
Secondary Hyperparathyroidism, End-stage Kidney Disease (ESKD)
Parathyroid Hormone (PTH) Attenuation Trial in Hemodialysis-1
This study is to evaluate the efficacy and safety of PLS240 in patients with hemodialysis-dependent end stage kidney disease (ESKD) and secondary hyperparathyroidism (SHPT). The study consists of two phases.
- Trial name
- PATH-1 (NCT05832931)
- Testing
- PLS240, Open-Label Extension PLS240
- Where
- 68 sites in United States, Bulgaria and 4 more
- Volunteers
- 362 people
- Sponsor
- Pathalys Pharma
Secondary Hyperparathyroidism in Patients With ESRD on Hemodialysis
Pharmacokinetics and Excretion of [¹⁴C]Etelcalcetide (AMG 416) in Patients With End Stage Renal Disease (ESRD) Receiving Dialysis
The primary objectives of this study were to determine the rate, extent, and routes of radioactivity excretion of [¹⁴C]etelcalcetide in feces, dialysate, and urine over time and to measure radioactivity concentrations in whole…
- Trial name
- NCT02054572
- Testing
- [¹⁴C]Etelcalcetide
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Amgen
Kidney Failure, Chronic, Chronic Kidney Disease-Mineral and Bone Disorder
DePTH: De-emphasize PTH
The De-emphasize Parathyroid Hormone (DePTH) Study is a 12-month pragmatic, randomized, parallel-group, active comparator, open-label, blinded end-point study of 90 patients with incident or prevalent secondary…
- Trial name
- NCT06288451
- Testing
- Oral calcitriol with cinacalcet rescue, IV activated vitamin D
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- University of Washington
CKD Stage 3, CKD Stage 4
Pharmacokinetics, Pharmacodynamics, Safety and Tolerability Evaluation of CTAP101 Extended-release Capsules in Pediatric Participants
The goal of this clinical trial is to evaluate safety, tolerability, and how CTAP101 Capsules work to treat Pediatric Participants with Secondary Hyperparathyroidism, Stage 3 or 4 Chronic Kidney Disease and Vitamin D…
- Conditions
- CKD Stage 3, CKD Stage 4, Secondary Hyperparathyroidism, VDI
- Trial name
- NCT07494045
- Testing
- CTAP101
- Where
- 5 sites in United States
- Volunteers
- 40 people
- Sponsor
- OPKO Health, Inc.
End Stage Renal Disease
Research Study Evaluating Cinacalcet for Patients With End Stage Renal Disease (ESRD)
The purpose of this study is to observe the effects of a treatment strategy that incorporates cinacalcet HCl into the management of secondary hyperparathyroidism (HPT) in subjects with ESRD receiving hemodialysis, on bio-intact…
- Trial name
- NCT00113945
- Testing
- Cinacalcet
- Volunteers
- 360 people
- Sponsor
- Amgen
Adynamic Bone Disease, Chronic Kidney Diseases
Treatment of Adynamic Bone Disorder With Parathyroid Hormone in Chronic Kidney Disease
This study is a 1:1 randomized controlled trial with an intervention for 18 months and a follow up period of 12 months. The purpose of the study is to assess the safety and efficacy of recombinant human parathyroid hormone for…
- Conditions
- Adynamic Bone Disease, Chronic Kidney Diseases, Cardiac Disease, Chronic Kidney Disease-Mineral and Bone Disorder
- Trial name
- NCT04522622
- Testing
- Teriparatide, DXA,VFA, X-ray, HR-pQCT, 18-F NAF PET/CT, Bone biopsy
- Where
- 4 sites in Denmark
- Volunteers
- 48 people
- Sponsor
- Ditte Hansen
Renal Osteodystrophy
Cholecalciferol Versus Doxercalciferol in the Treatment of Secondary Hyperparathyroidism in Chronic Kidney Disease
The majority of patients with moderate to severe chronic kidney disease (CKD) (stages 3 and 4) develop secondary hyperparathyroidism (2°HPT), but the optimal therapy to control hyperparathyroidism in this group is unknown.
- Trial name
- NCT00285467
- Testing
- doxercalciferol, Cholecalciferol
- Where
- United States
- Volunteers
- 55 people
- Sponsor
- Indiana University
Secondary Hyperparathyroidism, Chronic Kidney Disease
Head-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet
The purpose of this study is to demonstrate that treatment with etelcalcetide (AMG 416) is not inferior to treatment with cinacalcet for lowering serum parathyroid hormone (PTH) levels by > 30% from baseline among patients with…
- Trial name
- NCT01896232
- Testing
- Etelcalcetide, Cinacalcet
- Where
- 182 sites in United States, Austria and 20 more
- Volunteers
- 683 people
- Sponsor
- Amgen
Secondary Hyperparathyroidism
A Phase 4 Pharmacokinetic Study of Hectorol Injection and Zemplar Injection in CKD Subjects on Hemodialysis
This study will measure serum levels of the active Vitamin D compound that circulates in hemodialysis subjects treated with either doxercalciferol injection (Hectorol®) or Zemplar® (paricalcitol injection).
- Trial name
- NCT00454350
- Testing
- Hectorol (doxercalciferol injection), Zemplar (Paricalcitol injection)
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Genzyme, a Sanofi Company
Chronic Kidney Disease, Secondary Hyperparathyroidism
Evaluation of the Effectiveness of Paricalcitol Versus Cinacalcet With Low-Dose Vitamin D
Evaluates the effectiveness of on-label Paricalcitol versus Cinacalcet with Low-Dose Vitamin D.
- Conditions
- Chronic Kidney Disease, Secondary Hyperparathyroidism, Hemodialysis
- Trial name
- IMPACT SHPT (NCT00977080)
- Testing
- Paricalcitol, Cinacalcet
- Where
- 83 sites in United States, Czechia and 10 more
- Volunteers
- 272 people
- Sponsor
- Abbott
Hyperparathyroidism, Kidney Disease
Safety and Efficacy Study of Paricalcitol Versus Calcitriol in the Treatment of Secondary Hyperparathyroidism
The purpose of this study is to determine whether oral paricalcitol is safer and more efficacious compared to oral calcitriol in the treatment of hyperparathyroidism in chronic kidney disease patients undergoing dialysis.
- Trial name
- NCT00800358
- Testing
- Paricalitol, Calcitriol
- Where
- 11 sites in Malaysia
- Volunteers
- 69 people
- Sponsor
- Penang Hospital, Malaysia
Secondary Hyperparathyroidism
ACHIEVE: Optimizing the Treatment of Secondary Hyperparathyroidism
The purpose of this study is to compare the proportion of chronic kidney disease (CKD) subjects on dialysis receiving Sensipar® and low dose vitamin D or escalating doses of vitamin D alone who are able to achieve the National…
- Trial name
- NCT00135304
- Testing
- Sensipar®, Vitamin D
- Volunteers
- 170 people
- Sponsor
- Amgen