19 completed, 4 terminated. 12 Phase 4, 6 Phase 2, 3 Phase 3, 2 Phase 1, 1 Not applicable.
| Phase | Trials | Status |
|---|---|---|
| Phase 4 | 12 | Completed 11, Terminated 1 |
| Phase 2 | 6 | Completed 5, Terminated 1 |
| Phase 3 | 3 | Completed 2, Terminated 1 |
| Phase 1 | 2 | Completed 1, Terminated 1 |
| Not applicable | 1 | Completed 1 |
Follow 1 alpha-hydroxyergocalciferol: new trials by email Literature Review of 1 alpha-hydroxyergocalciferol trials Research Report on 1 alpha-hydroxyergocalciferol
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 |
|---|---|---|---|---|---|---|
| Safety and Efficacy of Hectorol in Pediatric Patients With Chronic Kidney Disease Stage 3 and 4 With Secondary Hyperparathyroidism Not Yet on Dialysis Doxercalciferol (GZ427397), Calcitriol - Secondary Hyperparathyroidism-Chronic Kidney Disease | Phase 3 | Terminated | Sanofi | 21 | 2017-01-19 | 2026-07-02 |
| Extension Study of CTAP101-CL-3001 or CTAP101-CL-3002 CTAP101 Capsules, Calcitriol, Doxercalciferol - Chronic Kidney Disease, Hyperparathyroidism, Secondary | Phase 3 | Completed | OPKO Health, Inc. | 298 | 2013-04-01 | 2016-09-29 |
| Trial to Optimize Mineral Outcomes in Dialysis Patients Cinacalcet, active vitamin D analogue - Secondary Hyperparathyroidism, Chronic Kidney Disease | Phase 4 | Completed | University of Colorado, Denver | 92 | 2010-03-01 | 2017-01-02 |
| Evaluation of the Effectiveness of Paricalcitol Versus Cinacalcet With Low-Dose Vitamin D Paricalcitol, Cinacalcet - Chronic Kidney Disease, Secondary Hyperparathyroidism | Phase 4 | Completed | Abbott | 272 | 2009-11-01 | 2012-06-20 |
| Pilot Study Evaluating Doxercalciferol Replacement Therapy in Kidney Transplant Recipients Doxercalciferol, placebo, 25-OH Vitamin D3 - Chronic Kidney Disease, Kidney Transplantation | Phase 4 | Completed | Mariana Markell | 39 | 2008-11-01 | 2019-02-22 |
| Comparison of I.V. CTAP201 and Doxercalciferol (Hectorol) in Subjects With Chronic Kidney Disease (CKD) and Secondary Hyperparathyroidism (SHPT) CTAP201 Injection, Doxercalciferol - Chronic Kidney Disease, Secondary Hyperparathyroidism | Phase 1 | Completed | OPKO IP Holdings II, Inc. | 24 | 2008-11-01 | 2014-09-29 |
| The Role of Vitamin D in Immune Function in Patients With Chronic Kidney Disease (CKD) Stages 3 and 4. cholecalciferol, doxercalciferol, placebo - Chronic Kidney Disease | Phase 4 | Completed | Indiana University | 100 | 2008-07-01 | 2013-03-29 |
| A Study to Evaluate the Safety and Effectiveness of Doxercalciferol Capsules in Participants With Moderate to Severe Psoriasis Doxercalciferol, Placebo - Moderate to Severe Chronic Plaque Psoriasis | Phase 2 | Completed | Genzyme, a Sanofi Company | 111 | 2008-04-01 | 2014-05-05 |
| Mineral Metabolism and Vascular Effects of Vitamin D Therapy in Kidney Transplant Patients doxercalciferol - Hyperparathyroidism, Secondary | Phase 4 | Terminated | Emory University | 12 | 2008-04-01 | 2015-01-26 |
| How Vitamin D Analogues Affect Endothelial Cells in Patients on Dialysis doxercalciferol - Hyperparathyroidism, Secondary, Kidney Failure, Chronic | Phase 4 | Completed | Duke University | 24 | 2007-09-01 | 2016-01-22 |
| Doxercalciferol in Recurrent Pediatric Solid Tumors Doxercalciferol - Solid Tumors | Phase 1 | Terminated | M.D. Anderson Cancer Center | 1 | 2007-08-01 | 2012-07-31 |
| A Phase 4 Study to Determine Dosing of Hectorol® Capsules When Converting From Zemplar® Injection Hectorol (doxercalciferol capsules), Zemplar (paricalcitol injection) - Secondary Hyperparathyroidism | Phase 4 | Completed | Genzyme, a Sanofi Company | 36 | 2007-04-01 | 2015-05-05 |
| A Phase 4 Pharmacokinetic Study of Hectorol Injection and Zemplar Injection in CKD Subjects on Hemodialysis Hectorol (doxercalciferol injection), Zemplar (Paricalcitol injection) - Secondary Hyperparathyroidism | Phase 4 | Completed | Genzyme, a Sanofi Company | 12 | 2007-02-01 | 2015-05-05 |
| A Phase 4, Conversion Study of Hectorol® Injection to Hectorol® Capsules in Stage 5 CKD Patients on Dialysis Hectorol® (doxercalciferol capsules), doxercalciferol capsules, Hectorol®, doxercalciferol capsules, Hectorol® capsules - Secondary Hyperparathyroidism | Phase 4 | Completed | Genzyme, a Sanofi Company | 36 | 2006-11-01 | 2015-03-19 |
| A Study of Zemplar® Injection and Hectorol® Injection on Intestinal Absorption of Calcium in Chronic Kidney Disease Zemplar® injection, Hectorol® injection - Chronic Kidney Disease, Stage 5, Secondary Hyperparathyroidism | Phase 4 | Completed | Abbott | 41 | 2006-06-01 | 2009-12-24 |
| Cholecalciferol Versus Doxercalciferol in the Treatment of Secondary Hyperparathyroidism in Chronic Kidney Disease doxercalciferol, Cholecalciferol - Renal Osteodystrophy | Not applicable | Completed | Indiana University | 55 | 2006-01-01 | 2016-05-02 |
| ACHIEVE: Optimizing the Treatment of Secondary Hyperparathyroidism Sensipar®, Vitamin D - Secondary Hyperparathyroidism | Phase 4 | Completed | Amgen | 170 | 2005-08-01 | 2014-02-11 |
| Study of Safety and Efficacy of Doxercalciferol in Patients With Chronic Kidney Disease, Stage 3 or 4, and Secondary Hyperparathyroidism Hectorol (doxercalciferol capsules), 0.5mcg - Secondary Hyperparathyroidism, Renal Failure | Phase 4 | Completed | Genzyme, a Sanofi Company | 70 | 2005-07-01 | 2015-05-05 |
| Doxercalciferol in Treating Patients With Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia doxercalciferol - Leukemia, Myelodysplastic Syndromes | Phase 2 | Completed | University of Wisconsin, Madison | 2002-09-01 | 2019-11-19 | |
| Study of Docetaxel With Doxercalciferol or Placebo for Advanced Prostate Cancer Docetaxel plus doxercalciferol, Docetaxel plus placebo - Prostate Cancer | Phase 2 | Terminated | University of Wisconsin, Madison | 70 | 2002-04-01 | 2019-12-13 |
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Hyperparathyroidism, Secondary (13) · Renal Insufficiency, Chronic (9) · Kidney Failure, Chronic (4) · Renal Insufficiency (3) · Chronic Kidney Disease-Mineral and Bone Disorder (2) · Hyperparathyroidism (2) · Kidney Diseases (2) · Parathyroid Diseases (2) · Prostatic Neoplasms (2) · Leukemia (1) · Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative (1) · Leukemia, Myelomonocytic, Chronic (1) · Myelodysplastic Syndromes (1) · Myelodysplastic-Myeloproliferative Diseases (1) · Myeloproliferative Disorders (1)
Genzyme, a Sanofi Company (5) · University of Wisconsin, Madison (3) · Abbott (2) · Indiana University (2) · Amgen (1) · Creighton University (1) · Duke University (1) · Emory University (1) · M.D. Anderson Cancer Center (1) · Mariana Markell (1) · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (1) · OPKO Health, Inc. (1) · OPKO IP Holdings II, Inc. (1) · Sanofi (1) · University of Colorado, Denver (1)
United States (20) · Chile (1) · Czechia (1) · Denmark (1) · Germany (1) · Greece (1) · Italy (1) · Netherlands (1) · Portugal (1) · Puerto Rico (1) · Russia (1) · Spain (1) · Sweden (1) · United Kingdom (1)
George Wilding, MD (2) · Joel Melnick, MD (2) · David M Spiegel, MD (1) · Isidro B Salusky, MD (1) · Jula Inrig, MD, MHS (1) · Lynda Szczech, MD (1) · Mariana Markell, MD (1) · Mark B. Juckett, MD (1) · Peter E. Zage, MD, PhD (1) · Samina Khan, MD (1) · Sharon M Moe, MD (1)
PMID 18203012, PMID 20056760, PMID 22387567, PMID 24214232, PMID 24500308, PMID 40576086, PMID 42564695
P30CA014520 (2), 2009 (1)