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This study will investigate how the levels of a repeat dose of CTAP101 changes in the body over time (pharmacokinetics, PK) and how CTAP101 affects other mineral and hormonal balances (pharmacodynamics, PD) in patients with chronic kidney disease (CKD, vitamin D insufficiency and secondary hyperparathyroidism (SHPT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: CTAP101 Capsules 60µg | Experimental |
| |
| Cohort 1: CTAP101 Capsules 90µg | Experimental |
| |
| Cohort 1: Sugar Capsule | Placebo Comparator |
| |
| Cohort 2: CTAP101 Capsules 30µg | Experimental |
| |
| Cohort 2: Sugar Capsule | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cohort 1 CTAP101 Capsules- 60µg | Drug | 60µg of CTAP101 capsules given once daily for 42 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion (%) of Subjects With Serum 25-hydroxyvitamin D ≥30 ng/mL (PP). | The proportion of subjects in the per protocol population with serum 25-hydroxyvitamin D ≥30 ng/mL at End-of-Treatment (EOT; Week 6) in Cohorts 1 and 2 (60/90 and 30 μg groups, respectively) were compared to their corresponding placebo groups. | 6 weeks |
| Mean Percent Change From Baseline in Plasma Intact Parathyroid Hormone (iPTH) to End of Treatment (Per Protocol Population) | Mean percent change from baseline in plasma intact parathyroid hormone (iPTH) from baseline to End of Treatment (EOT) in the Per Protocol population. Subjects in Cohorts 1 and 2 (dose regimens 60/90 and 30 mcg, respectively) were compared to their respective placebo groups. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Serum 25-hydroxyvitamin D at Week 6 | Mean absolute change from baseline in serum total 25-hydroxyvitamin D to end of treatment (EOT) | Baseline to End of Treatment (6 weeks) |
| Percent Change From Baseline in Serum 25-hydroxyvitamin D at End of Treatment (EOT, Week 6) in the Per Protocol Population |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joel Melnick, MD | OPKO Health, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OPKO Health, Inc | Bannockburn | Illinois | 60015 | United States |
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This trial randomized 78 subjects. One subject in the 90 µg treatment arm was lost to follow-up after randomization but before receiving study drug. This subject was excluded from the Intent to Treat population (ITT).
Subjects with Stage 3 chronic kidney disease, vitamin D insufficiency and secondary parahyperthyroidism were recruited from 16 sites within the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: CTAP101 Capsules 60µg | Cohort 1 CTAP101 Capsules- 60µg: 60µg of CTAP101 capsules given once daily for 42 days. |
| FG001 | Cohort 1: CTAP101 Capsules 90µg | Cohort 1 CTAP101 Capsules - 90µg: 90µg of CTAP101 capsules given once daily for 42 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Cohort 1 CTAP101 Capsules - 90µg | Drug | 90µg of CTAP101 capsules given once daily for 42 days. |
|
| Cohort 1 Matching Sugar Capsule | Drug | Placebo capsules given once daily for 42 days. |
|
| Cohort 2 CTAP101 Capsules - 30µg | Drug | 30µg of CTAP101 capsules given once daily for 42 days. |
|
| Cohort 2 Matching Sugar Capsule | Drug | Placebo capsules given once daily for 42 days. |
|
Mean percent change from baseline in serum 25-hydroxyvitamin D at End of Treatment (EOT, week 6) in the per protocol population. Subjects in Cohorts 1 and 2 (dose regimens of 60/90 and 30 mcg, respectively) were compared versus their corresponding placebo groups. |
| Baseline to End of Treatment (6 weeks) |
| Proportion of Subjects With Reduction of Intact Parathyroid Hormone (iPTH) of at Least 30% at Week 6 | Proportion of subjects with at least 30% reduction in plasma intact parathyroid hormone (iPTH) and/or mean iPTH reduction to 70 pg/mL or less at End of Treatment (EOT) | Baseline to End of Treatment (6 weeks) |
| Proportion of Subjects With Reduction of Intact Parathyroid Hormone (iPTH) of at Least 20% at Week 6 | Proportion of subjects with at least 20% reduction in plasma intact parathyroid hormone (iPTH) and/or mean iPTH reduction to 70 pg/mL or less at End of Treatment (EOT) | Baseline to End of Treatment (6 weeks) |
| FG002 | Cohort 1: Sugar Capsule | Cohort 1 Matching Sugar Capsule: Placebo capsules given once daily for 42 days. |
| FG003 | Cohort 2: CTAP101 Capsules 30µg | Cohort 2 CTAP101 Capsules - 30µg: 30µg of CTAP101 capsules given once daily for 42 days. |
| FG004 | Cohort 2: Sugar Capsule | Cohort 2 Matching Sugar Capsule: Placebo capsules given once daily for 42 days. |
| COMPLETED |
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| NOT COMPLETED |
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Intent to treat population (excludes a single subject randomized to the 90 µg treatment arm who was lost to follow-up prior to receiving study drug)
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: CTAP101 Capsules 60µg | Cohort 1 CTAP101 Capsules- 60µg: 60µg of CTAP101 capsules given once daily for 42 days. |
| BG001 | Cohort 1: CTAP101 Capsules 90µg | Cohort 1 CTAP101 Capsules - 90µg: 90µg of CTAP101 capsules given once daily for 42 days. |
| BG002 | Cohort 1: Sugar Capsule | Cohort 1 Matching Sugar Capsule: Placebo capsules given once daily for 42 days. |
| BG003 | Cohort 2: CTAP101 Capsules 30µg | Cohort 2 CTAP101 Capsules - 30µg: 30µg of CTAP101 capsules given once daily for 42 days. |
| BG004 | Cohort 2: Sugar Capsule | Cohort 2 Matching Sugar Capsule: Placebo capsules given once daily for 42 days. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion (%) of Subjects With Serum 25-hydroxyvitamin D ≥30 ng/mL (PP). | The proportion of subjects in the per protocol population with serum 25-hydroxyvitamin D ≥30 ng/mL at End-of-Treatment (EOT; Week 6) in Cohorts 1 and 2 (60/90 and 30 μg groups, respectively) were compared to their corresponding placebo groups. | Per protocol | Posted | Number | percentage of participants | 6 weeks |
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Mean Percent Change From Baseline in Plasma Intact Parathyroid Hormone (iPTH) to End of Treatment (Per Protocol Population) | Mean percent change from baseline in plasma intact parathyroid hormone (iPTH) from baseline to End of Treatment (EOT) in the Per Protocol population. Subjects in Cohorts 1 and 2 (dose regimens 60/90 and 30 mcg, respectively) were compared to their respective placebo groups. | Per protocol | Posted | Mean | Standard Deviation | percentage of change from baseline | 6 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Serum 25-hydroxyvitamin D at Week 6 | Mean absolute change from baseline in serum total 25-hydroxyvitamin D to end of treatment (EOT) | Per protocol population | Posted | Mean | Standard Deviation | ng/mL | Baseline to End of Treatment (6 weeks) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Serum 25-hydroxyvitamin D at End of Treatment (EOT, Week 6) in the Per Protocol Population | Mean percent change from baseline in serum 25-hydroxyvitamin D at End of Treatment (EOT, week 6) in the per protocol population. Subjects in Cohorts 1 and 2 (dose regimens of 60/90 and 30 mcg, respectively) were compared versus their corresponding placebo groups. | Per protocol population | Posted | Mean | Standard Deviation | percentage of change from baseline | Baseline to End of Treatment (6 weeks) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Subjects With Reduction of Intact Parathyroid Hormone (iPTH) of at Least 30% at Week 6 | Proportion of subjects with at least 30% reduction in plasma intact parathyroid hormone (iPTH) and/or mean iPTH reduction to 70 pg/mL or less at End of Treatment (EOT) | Per protocol | Posted | Number | participants | Baseline to End of Treatment (6 weeks) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Subjects With Reduction of Intact Parathyroid Hormone (iPTH) of at Least 20% at Week 6 | Proportion of subjects with at least 20% reduction in plasma intact parathyroid hormone (iPTH) and/or mean iPTH reduction to 70 pg/mL or less at End of Treatment (EOT) | Per protocol population | Posted | Number | participants | Baseline to End of Treatment (6 weeks) |
|
12 weeks (6 week treatment period, followed by 6 week follow-up period)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohorts 1,2: Sugar Capsule | Cohort 1 Matching Sugar Capsule: Placebo capsules given once daily for 42 days. | 1 | 31 | 22 | 31 | ||
| EG001 | Cohort 2: CTAP101 Capsules 30µg | Cohort 2 CTAP101 Capsules - 30µg: 30µg of CTAP101 capsules given once daily for 42 days. | 1 | 13 | 8 | 13 | ||
| EG002 | Cohort 1: CTAP101 Capsules 60µg | Cohort 1 CTAP101 Capsules- 60µg: 60µg of CTAP101 capsules given once daily for 42 days. | 1 | 17 | 12 | 17 | ||
| EG003 | Cohort 1: CTAP101 Capsules 90µg | Cohort 1 CTAP101 Capsules - 90µg: 90µg of CTAP101 capsules given once daily for 42 days. | 1 | 16 | 10 | 16 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment | Unrelated to study drug |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment | Unrelated to study drug |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 15.1 | Non-systematic Assessment | Unrelated to study drug |
|
| Angioplasty | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment | Unrelated to study drug |
|
| Hypoglycaemia | Endocrine disorders | MedDRA 15.1 | Non-systematic Assessment | Unrelated to study drug |
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| Acute prerenal failure | Renal and urinary disorders | MedDRA 15.1 | Non-systematic Assessment | Unrelated to study drug |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment | Unrelated to study drug |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Hypoglycaemia | Endocrine disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Frequent bowel movements | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Tooth impacted | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Animal bite | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Fractured sacrum | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Patella fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Blood 25-hydroxycholecalciferol increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Body temperature increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Vitamin D increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Hyperphosphatemia | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Magnesium deficiency | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Joint warmth | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Tearfulness | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Telangiectasia | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Asthma prophylaxis | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Vessel puncture site haematoma | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Flank pain | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Eschar | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Sunburn | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Blood uric acid increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Hypogeusia | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Sensory loss | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Douglass Laidlaw, PhD, Vice President, Medical Affairs | OPKO Health, Inc. | 305-575-4172 | dlaidlaw@opko.com |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D006962 | Hyperparathyroidism, Secondary |
| D010279 | Parathyroid Diseases |
| D051437 | Renal Insufficiency |
| D007676 | Kidney Failure, Chronic |
| 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 |
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| Male |
|
| OG004 | Cohort 2: Sugar Capsule | Cohort 2 Matching Sugar Capsule: Placebo capsules given once daily for 42 days. |
|
|
|
Cohort 2 Matching Sugar Capsule: Placebo capsules given once daily for 42 days. |
|
|
|
Cohort 2 CTAP101 Capsules - 30µg: 30µg of CTAP101 capsules given once daily for 42 days.
| OG004 | Cohort 2: Sugar Capsule | Cohort 2 Matching Sugar Capsule: Placebo capsules given once daily for 42 days. |
|
|
|
| OG004 |
| Cohort 2: Sugar Capsule |
Cohort 2 Matching Sugar Capsule: Placebo capsules given once daily for 42 days. |
|
|
|
| OG004 | Cohort 2: Sugar Capsule | Cohort 2 Matching Sugar Capsule: Placebo capsules given once daily for 42 days. |
|
|
|