Clinical trials: Hyperparathyroidism
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
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
Secondary Hyperparathyroidism Due to Renal Causes, Chronic Kidney Diseases
Safety, Efficacy, PK and PD of CTAP101 (Calcifediol) ER Capsules for SHPT in HD Patients VDI
Safety, Efficacy, PK and PD of CTAP101 (calcifediol) ER Capsules for SHPT in HD Patients VDI
- Conditions
- Secondary Hyperparathyroidism Due to Renal Causes, Chronic Kidney Diseases, Vitamin D Deficiency, Stage 5 Chronic Kidney Disease
- Trial name
- NCT03602261
- Testing
- Calcifediol Oral Capsule
- Where
- 18 sites in United States
- Volunteers
- 44 people
- Sponsor
- OPKO Health, Inc.
Parathyroid Diseases, Parathyroid Dysfunction
Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Parathyroidectomy
The goal of this study is to assess whether using PTeye (AiBiomed, Santa Barbara, CA) - a NIRAF detection modality - can improve patient outcomes and reduce healthcare associated costs after parathyroid surgeries.
- Conditions
- Parathyroid Diseases, Parathyroid Dysfunction, Parathyroid Neoplasms, Parathyroid Adenoma
- Trial name
- NCT05152927
- Testing
- Parathyroid Eye (PTeye)
- Where
- United States
- Volunteers
- 79 people
- Sponsor
- University of California, San Francisco
Parathyroid Adenoma, Parathyroid Neoplasms
Evaluating Impact of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Parathyroidectomy
This study will see if the use of near infrared autofluorescence (NIRAF) detection with an FDA-cleared device 'Parathyroid Eye (PTeye)' for identifying parathyroid glands (PGs) during parathyroidectomy (PTx) procedures is better…
- Conditions
- Parathyroid Adenoma, Parathyroid Neoplasms, Parathyroid Cancer, Hypercalcemia
- Trial name
- NCT05022641
- Testing
- PTeye, Standard of Care
- Where
- United States
- Volunteers
- 160 people
- Sponsor
- University of Michigan
Chronic Kidney Disease stage3, Chronic Kidney Disease stage4
Phase 3 Safety and Efficacy Study of CTAP101 Extended-release Capsules in Children With Secondary Hyperparathyroidism
This is a phase 3, multi-center, randomized, double-blind, placebo-controlled study in children with stage 3-4 chronic kidney disease (CKD), secondary hyperparathyroidism (SHPT) and vitamin D insufficiency.
- Conditions
- Chronic Kidney Disease stage3, Chronic Kidney Disease stage4, Vitamin d Deficiency, Secondary Hyperparathyroidism
- Trial name
- NCT05543928
- Testing
- CTAP101
- Where
- 2 sites in United States
- Volunteers
- 2 people
- Sponsor
- OPKO Health, Inc.
Secondary Hyperparathyroidism, Hypercalcemia
Cinacalcet to Treat Hypercalcemia in Renal Transplant Recipients
Secondary hyperparathyroidism can persist following successful renal transplantation and can cause high blood calcium, kidney dysfunction or failure and excessive bone loss among other problems.
- Trial name
- NCT00415584
- Testing
- Cinacalcet HCl
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Montefiore Medical Center
End Stage Renal Disease, Kidney Transplantation
Bone Mass and Strength After Kidney Transplantation
The purpose of this study is to test whether active vitamin D (calcitriol) protects bones from weakening and protects blood vessels from calcium deposits over the first year of kidney transplantation.
- Conditions
- End Stage Renal Disease, Kidney Transplantation, Bone Loss, Fractures
- Trial name
- NCT02224144
- Testing
- Vitamin D3, Calcitriol
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- Columbia University
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
- NCT01651000
- Testing
- CTAP101 30 μg capsules, Sugar pill to CTAP101 30 μg capsules
- Where
- United States
- Volunteers
- 213 people
- Sponsor
- OPKO IP Holdings II, Inc.
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.
Parathyroid Adenoma, Parathyroid Neoplasms
Evaluating Impact of NIRAF Detection for Identifying Parathyroid Glands During Parathyroidectomy
This study describes a single center, randomized, single-blinded clinical trial to assess the clinical benefits of the use of near infrared autofluorescence (NIRAF) detection with an FDA-cleared device 'Parathyroid Eye (PTeye)'…
- Conditions
- Parathyroid Adenoma, Parathyroid Neoplasms, Parathyroid Hyperplasia, Parathyroid Cancer
- Trial name
- NIRAF (NCT04299425)
- Testing
- NIRAF Detection Technology
- Where
- United States
- Volunteers
- 160 people
- Sponsor
- Vanderbilt-Ingram Cancer Center
Kidney Failure, Secondary Hyperparathyroidism
Management of Mineral and Bone Disease in Hemodialysis-Calcitriol vs. Paricalcitol
The purpose of this non-inferiority study is to compare the safety and effectiveness of a mineral and bone disease treatment protocol based on calcitriol to one based on paricalcitol in hemodialysis patients using revised Kidney…
- Conditions
- Kidney Failure, Secondary Hyperparathyroidism, Hyperphosphatemia, Hypercalcemia
- Trial name
- ECRIP (NCT01725113)
- Testing
- Calcitriol, Paricalcitol
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Winthrop University Hospital
Cardiovascular Disease, Chronic Kidney Disease
Vascular Risk After Kidney Transplantation
Hypothesis: Nontraditional risk factors, such as inflammation, vitamin D deficiency, elevated PTH, insulin resistance, homocysteine, or uric acid, contribute to cardiovascular disease progression after kidney transplant.
- Conditions
- Cardiovascular Disease, Chronic Kidney Disease, Diabetes, Vitamin D Deficiency
- Trial name
- NCT00374595
- Where
- United States
- Volunteers
- 338 people
- Sponsor
- University of Nebraska
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
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
Primary Hyperparathyroidism
Evaluating Alternative Medical Therapies in Primary Hyperparathyroidism
This study will evaluate whether blocking the mineralocorticoid receptor, alone, or in combination with the calcimimetic cinacalcet, can lower parathyroid hormone and calcium levels in primary hyperparathyroidism.
- Trial name
- NCT02525796
- Testing
- eplerenone, amiloride, Cinacalcet
- Where
- United States
- Volunteers
- 69 people
- Sponsor
- Brigham and Women's Hospital
Secondary Hyperparathyroidism Due to Renal Causes, Vitamin D Insufficiency
Repeated-dose Safety, Efficacy, Pharmacokinetic and Pharmacodynamic of CTAP101, Immediate-release Calcifediol, High-dose Cholecalciferol, and Paricalcitol Plus Low-dose Cholecalciferol in Patients With Secondary Hyperparathyroidism, Chronic Kidney Disease 3-4 and Vitamin D Insufficiency
An Open-Label, Repeated-Dose Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Study of Oral CTAP101 Capsules, Immediate- Release (IR) Calcifediol, High-Dose Cholecalciferol, and Paricalcitol Plus Low-Dose Cholecalciferol in…
- Conditions
- Secondary Hyperparathyroidism Due to Renal Causes, Vitamin D Insufficiency, CKD Stage 3, CKD Stage 4
- Trial name
- NCT03588884
- Testing
- Calcifediol Oral Capsule, Calcifediol Oral Product, Cholecalciferol
- Where
- 3 sites in United States
- Volunteers
- 69 people
- Sponsor
- OPKO Health, Inc.
Secondary Hyperparathyroidism, Chronic Kidney Disease
E.V.O.L.V.E. Trial™: EValuation Of Cinacalcet Hydrochloride (HCl) Therapy to Lower CardioVascular Events
The purpose of this study is to evaluate the effects of cinacalcet (cinacalcet HCl or Sensipar®/Mimpara®) on cardiovascular events and death in chronic kidney disease (CKD) patients with secondary hyperparathyroidism (HPT) who…
- Trial name
- EVOLVE (NCT00345839)
- Testing
- Cinacalcet
- Volunteers
- 3,883 people
- Sponsor
- Amgen
Primary Hyperparathyroidism
Denosumab in Primary Hyperparathyroidism
Primary hyperparathyroidism (PHPT), a disease characterized by excess parathyroid hormone (PTH) and high blood calcium, is one of the most common endocrine disorders. PHPT is seen most often in postmenopausal women.
- Trial name
- NCT01558115
- Testing
- Denosumab
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Columbia University
Hyperparathyroidism, Hypercalcemia
Studies of Elevated Parathyroid Activity
Observational Phase: Patients whose parathyroid activity is elevated above normal are referred to as having hyperparathyroidism.
- Conditions
- Hyperparathyroidism, Hypercalcemia, Parathyroid Neoplasm, Multiple Endocrine Neoplasia
- Trial name
- NCT00001277
- Testing
- 68Ga-Dotatate, 18F-DOPA
- Where
- United States
- Volunteers
- 1,553 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)