Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will investigate the levels of CTA018 in the body over time (pharmacokinetics, PK) in patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT), undergoing regular hemodialysis. This study will also investigate the safety and effects of different strengths of CTA018, on parathyroid hormone (PTH) levels.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CTA018 Injection low dose | Experimental | Low dose IV 3 times a week for 4 weeks |
|
| CTA018 Injection low to mid dose | Experimental | low to mid dose IV 3 times a week for 4 weeks |
|
| CTA018 Injection mid to high dose | Experimental | mid to high dose IV 3 times a week for 4 weeks |
|
| CTA018 Injection high dose | Experimental | high dose IV 3 times a week for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CTA018 Injection | Drug | Comparison of different dosages of drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the single and repeat dose pharmacokinetics (PK) of CTA018 Injection | Day 1 and 12 of each dose level | |
| To investigate the safety of CTA018 Injection | Throughout the study |
| Measure | Description | Time Frame |
|---|---|---|
| To investigate the pharmacodynamic (PD) intact parathyroid hormone (iPTH) response following CTA08 Injection | Throughout the study | |
| To determine the efficacy of CTA018 Injection to reduce serum iPTH | Throughout the study |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Joel Melnick, MD | OPKO Renal | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pines Clinical Research, Inc. | Pembroke Pines | Florida | 33028 | United States | ||
| Boise Kidney and Hypertension Institute |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Meridian |
| Idaho |
| 83642 |
| United States |
| Western New England Renal & Transplant Associates (WNERTA) | Springfield | Massachusetts | 01107-1121 | United States |
| Southeast Renal Research Institute | Chattanooga | Tennessee | 37404 | United States |
| U.S. Renal Care | Fort Worth | Texas | 76105 | United States |
| Capital District Heatlth Authority: Centre for Clinical Research | Halifax | Nova Scotia | B3H 1V8 | Canada |
| St. Joseph's Health Care London | London | Ontario | N6A 4V2 | Canada |
| St. Michael's Hospital | Toronto | Ontario | M5N 1W8 | Canada |
| Humber River Regional Hospital | Weston | Ontario | M9N 1N8 | Canada |
| Hôpital Charles-Lemoyne | Greenfield Park | Quebec | J4V 2H1 | Canada |
| Hôpital du Sacré-Coeur de Montréal | Montreal | Quebec | H4J 1C5 | Canada |
| Hospital de Verdun | Verdun | Quebec | H4G 2A3 | Canada |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D006962 | Hyperparathyroidism, Secondary |
| D007676 | Kidney Failure, Chronic |
| D010279 | Parathyroid Diseases |
| D051437 | Renal Insufficiency |
| D006961 | Hyperparathyroidism |
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004700 | Endocrine System Diseases |
Not provided
Not provided