16 completed, 3 unknown, 2 terminated, 1 recruiting. 22 Phase 2, 3 Phase 3, 1 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 22 | Completed 16, Unknown 3, Terminated 2, Recruiting 1 |
| Phase 3 | 3 | Completed 2, Unknown 1 |
| Phase 1 | 1 | Terminated 1 |
Follow Secondary Hyperparathyroidism: new trials by email Literature Review of Secondary Hyperparathyroidism trials Research Report on Secondary Hyperparathyroidism
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Pharmacokinetics, Pharmacodynamics, Safety and Tolerability Evaluation of CTAP101 Extended-release Capsules in Pediatric Participants CTAP101 - CKD Stage 3, CKD Stage 4 | Phase 2 | Recruiting | OPKO Health, Inc. | 40 | 2026-08-05 | 2026-08-20 |
| The Effect of Increasing Dialysate Calcium on T50 in Subjects With Secondary Hyperparathyroidism and ESKD Dialysate calcium 1.50 mmol/L - Secondary Hyperparathyroidism, End-stage Kidney Disease | Phase 2 | Unknown | Iain Bressendorff | 48 | 2024-08-01 | 2024-05-03 |
| A Study of SHR6508 in Secondary Hyperparathyroidism SHR6508, Cinacalcet - Secondary Hyperparathyroidism | Phase 2 | Unknown | Shanghai Hengrui Pharmaceutical Co., Ltd. | 75 | 2023-02-24 | 2023-06-18 |
| Dose Adjustment Trial of SK-1403 in Hemodialysis Patients With Secondary Hyperparathyroidism Dose-adjusted SK-1403 - Secondary Hyperparathyroidism | Phase 2 | Completed | Sanwa Kagaku Kenkyusho Co., Ltd. | 58 | 2017-06-20 | 2019-03-15 |
| Phase 3 Study of KHK7580 KHK7580, KRN1493 - Secondary Hyperparathyroidism | Phase 2 / Phase 3 | Completed | Kyowa Kirin Co., Ltd. | 634 | 2015-09-01 | 2017-03-24 |
| Phase 2 Study of KHK7580 Placebo, KHK7580 low dose, KHK7580 middle dose - Secondary Hyperparathyroidism | Phase 2 | Completed | Kyowa Kirin Co., Ltd. | 201 | 2014-07-01 | 2018-07-10 |
| A Study to Evaluate the Effect of ASP7991 in Secondary Hyperparathyroidism Patients Undergoing Hemodialysis ASP7991, Cinacalcet, Placebo - Secondary Hyperparathyroidism | Phase 2 | Completed | Astellas Pharma Inc | 62 | 2014-03-14 | 2024-11-06 |
| A Phase 2A Dose-ranging and Pharmacokinetic Study of an Oral Vitamin D Compound (DP001) in Secondary Hyperparathyroidism DP001 - Secondary Hyperparathyroidism | Phase 2 | Completed | Deltanoid Pharmaceuticals | 42 | 2012-08-01 | 2017-08-16 |
| Open-label Study to Assess the Long-term Safety and Efficacy of Etelcalcetide (Also Known as AMG 416 or KAI-4169) in Patients With Secondary Hyperparathyroidism Etelcalcetide - Secondary Hyperparathyroidism | Phase 2 | Terminated | KAI Pharmaceuticals | 30 | 2012-03-01 | 2017-04-13 |
| Etelcalcetide to Treat Secondary Hyperparathyroidism in Hemodialysis Patients With Chronic Kidney Disease-Mineral and Bone Disorder Etelcalcetide - Secondary Hyperparathyroidism | Phase 2 | Completed | KAI Pharmaceuticals | 37 | 2011-12-05 | 2017-04-11 |
| Safety, Tolerability and Efficacy of Etelcalcetide in Hemodialysis Patients With Secondary Hyperparathyroidism Etelcalcetide, Placebo - Secondary Hyperparathyroidism | Phase 2 | Completed | KAI Pharmaceuticals | 87 | 2011-02-20 | 2017-04-13 |
| Safety/Efficacy Study of CTAP101 in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism (SHPT) Cohort 1 CTAP101 Capsules- 60µg, Cohort 1 CTAP101 Capsules - 90µg, Cohort 1 Matching Sugar Capsule - Chronic Kidney Disease, Secondary Hyperparathyroidism | Phase 2 / Phase 3 | Completed | OPKO Health, Inc. | 78 | 2010-10-01 | 2016-08-25 |
| Cinacalcet in Paediatric Secondary Hyperparathyroidism (SHPT) Due to Chronic Kidney Disease (CKD) Cinacalcet HCl - Secondary Hyperparathyroidism | Phase 2 / Phase 3 | Unknown | ENRICO VERRINA | 30 | 2010-03-01 | 2011-11-24 |
| Paricalcitol Compared to Maxacalcitol in Chronic Kidney Disease Patients With Secondary Hyperparathyroidism paricalcitol, maxacalcitol - Secondary Hyperparathyroidism, Hemodialysis | Phase 2 | Completed | Abbott | 47 | 2009-10-01 | 2011-07-11 |
| Paricalcitol in Reducing Parathyroid Hormone Levels and Ameliorating Markers of Bone Remodelling in Renal Transplant Recipients With Secondary Hyperparathyroidism Paricalcitol, Standard therapy - Renal Transplant, Secondary Hyperparathyroidism | Phase 2 | Completed | Mario Negri Institute for Pharmacological Research | 43 | 2009-09-01 | 2013-02-22 |
| Safety Study of CTA018 Injection to Treat Stage 5 Chronic Kidney Disease CTA018 Injection - Chronic Kidney Disease, Secondary Hyperparathyroidism | Phase 2 | Completed | OPKO IP Holdings II, Inc. | 41 | 2008-10-01 | 2014-11-06 |
| Long-term Safety Study of Paricalcitol Injection in Chronic Kidney Disease Patients With Hemodialysis (HD) Paricalcitol - Secondary Hyperparathyroidism, Hemodialysis | Phase 2 | Completed | Abbott | 107 | 2008-07-01 | 2011-04-19 |
| Dose-response Study of Paricalcitol Injection in Chronic Kidney Disease Patients Receiving Hemodialysis Maxacalcitol, Paricalcitol - Chronic Kidney Disease on Hemodialysis, Secondary Hyperparathyroidism | Phase 2 | Completed | Abbott | 153 | 2008-04-01 | 2012-01-20 |
| Cinacalcet to Treat Hypercalcemia in Renal Transplant Recipients Cinacalcet HCl - Secondary Hyperparathyroidism, Hypercalcemia | Phase 1 / Phase 2 | Terminated | Montefiore Medical Center | 4 | 2007-02-09 | 2025-04-29 |
| Bone Biopsy Study For Dialysis Patients With Secondary Hyperparathyroidism of End Stage Renal Disease Sensipar (Cinacalcet HCl) - Secondary Hyperparathyroidism | Phase 2 | Completed | Amgen | 110 | 2006-05-01 | 2014-07-21 |
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Hyperparathyroidism, Secondary (22) · Renal Insufficiency, Chronic (6) · Chronic Kidney Disease-Mineral and Bone Disorder (3) · Kidney Failure, Chronic (3) · Hyperparathyroidism (2) · Kidney Diseases (2) · Parathyroid Diseases (2) · Renal Insufficiency (2) · Hypercalcemia (1)
Endocrine System Diseases (22) · Hyperparathyroidism (20) · Parathyroid Diseases (20) · Chronic Disease (10) · Disease Attributes (10) · Female Urogenital Diseases (10) · Female Urogenital Diseases and Pregnancy Complications (10) · Male Urogenital Diseases (10) · Pathologic Processes (10) · Pathological Conditions, Signs and Symptoms (10) · Urogenital Diseases (10) · Urologic Diseases (10) · Kidney Diseases (8) · Renal Insufficiency (5) · Calcium Metabolism Disorders (4)
Cinacalcet (8) · paricalcitol (4) · etelcalcetide hydrochloride (3) · maxacalcitol (2) · 1 alpha-hydroxyergocalciferol (1) · ASP7991 (1) · Calcitriol (1) · Calcium Carbonate (1) · Sevelamer (1) · Standard of Care (1)
Abbott (3) · KAI Pharmaceuticals (3) · Amgen (2) · Kyowa Kirin Co., Ltd. (2) · OPKO Health, Inc. (2) · Astellas Pharma Inc (1) · Deltanoid Pharmaceuticals (1) · ENRICO VERRINA (1) · Iain Bressendorff (1) · Mario Negri Institute for Pharmacological Research (1) · Montefiore Medical Center (1) · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (1) · OPKO IP Holdings II, Inc. (1) · Sanwa Kagaku Kenkyusho Co., Ltd. (1) · Shanghai Hengrui Pharmaceutical Co., Ltd. (1)
Japan (7) · United States (7) · Italy (3) · Belgium (1) · Canada (1) · China (1) · Czechia (1) · Hungary (1) · North Macedonia (1) · Poland (1) · Portugal (1) · Spain (1) · Switzerland (1) · Turkey (Türkiye) (1) · United Kingdom (1)
Joel Melnick, MD (2) · M D (2) · Enrico E. Verrina, MD (1) · Gregory Bell, MD (1) · Iain Bressendorff, MD PhD (1) · Isidro B Salusky, MD (1) · Maria Coco, MD, MS (1) · Moriaki Kubo (1) · Ravi Thadhani, MD (1) · Ryotaro Matsuzawa (1)
PMID 15983958, PMID 23222688, PMID 35176038, PMID 36512619, PMID 40576086
2008 (1), 2009 (1)