Secondary Hyperparathyroidism-Chronic Kidney Disease Clinical Trial
Official title:
An Open-Label, Randomized, Parallel Group Study to Assess the Safety and Efficacy of Hectorol® (Doxercalciferol Capsules) in Pediatric Patients With Chronic Kidney Disease Stages 3 and 4 With Secondary Hyperparathyroidism Not Yet on Dialysis
| Verified date | April 2023 |
| Source | Sanofi |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Primary Objective: Evaluate the effect of Hectorol® capsules in reducing elevated levels of intact parathyroid hormone (iPTH). Secondary Objectives: - Evaluate the safety profile of Hectorol® capsules versus Rocaltrol® (calcitriol) capsules. - Determine the pharmacokinetic profile of 1,25-dihydroxyvitamin D2 after administration of Hectorol®.
| Status | Active, not recruiting |
| Enrollment | 84 |
| Est. completion date | November 12, 2025 |
| Est. primary completion date | November 12, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 5 Years to 18 Years |
| Eligibility | Inclusion criteria : - Male or female aged 5 to 18 years old. - Weight =15 kg. - Chronic kidney disease (CKD) Stage 3 or 4 not on dialysis, defined as glomerular filtration rate (GFR) between 15 and 59 mL/min/1.73m^2 (established by Schwartz equation) at Week -2 visit. - Intact parathyroid hormone (iPTH) value >100 pg/mL for CKD Stage 3 or >160 pg/mL for CKD Stage 4, at Week -2 visit. - Signed informed consent/assent form. Exclusion criteria: - The patient has a serum 25-hydroxyvitamin D level <30 ng/mL at screening. - The patient has a corrected calcium =10 mg/dL at the Week -2 visit. - The patient has a serum phosphorus >4.5 mg/dL for children 13 to 18 years of age; >5.8 mg/dL for children 5 to 12 years of age at the Week -2 visit. - The patient is anticipated to require maintenance hemodialysis within 3 months. - The patient used cinacalcet or vitamin D sterol therapies such as calcitriol, doxercalciferol, or paricalcitol within 14 days prior to the baseline visit. - The patient has a history of, or active, symptomatic heart disease within 12 months prior to the baseline (Week 0) visit. - The patient currently has a chronic gastrointestinal disease (ie, malabsorption, severe chronic diarrhea, chronic ulcerative colitis, or ileostomy). - The patient currently has primary hyperparathyroidism or has had a total parathyroidectomy. - The patient has an active malignancy. - The patient is unable to swallow a capsule in size similar to the Hectorol® and Rocaltrol® capsules. - The patient has a history of sensitivity or allergy to doxercalciferol, calcitriol or other vitamin D analogs. - The patient currently uses aluminum or magnesium-based binders. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. |
| Country | Name | City | State |
|---|---|---|---|
| Chile | Investigational Site Number :1520004 | Concepción | Biobío |
| Chile | Investigational Site Number :1520003 | Santiago | Reg Metropolitana De Santiago |
| United States | Investigational Site Number :8400022 | Birmingham | Alabama |
| United States | Investigational Site Number :8400020 | Chicago | Illinois |
| United States | Investigational Site Number :8400034 | Durham | North Carolina |
| United States | Investigational Site Number :8400025 | Greenville | North Carolina |
| United States | Investigational Site Number :8400027 | Greenville | South Carolina |
| United States | Investigational Site Number :8400010 | Hackensack | New Jersey |
| United States | Investigational Site Number :8400013 | Houston | Texas |
| United States | Investigational Site Number :8400019 | Houston | Texas |
| United States | Investigational Site Number :8400036 | Indianapolis | Indiana |
| United States | Investigational Site Number :8400015 | Jackson | Mississippi |
| United States | Investigational Site Number :8400023 | Los Angeles | California |
| United States | Investigational Site Number :8400033 | Los Angeles | California |
| United States | Investigational Site Number :8400001 | Marshfield | Wisconsin |
| United States | Investigational Site Number :8400006 | Miami | Florida |
| United States | Investigational Site Number :8400008 | Miami | Florida |
| United States | Investigational Site Number :8400014 | Minneapolis | Minnesota |
| United States | Investigational Site Number :8400016 | Morristown | New Jersey |
| United States | Investigational Site Number :8400024 | Nashville | Tennessee |
| United States | Investigational Site Number :8400029 | New Haven | Connecticut |
| United States | Investigational Site Number :8400017 | New Hyde Park | New York |
| United States | Investigational Site Number :8400007 | New York | New York |
| United States | Investigational Site Number :8400028 | Pittsburgh | Pennsylvania |
| United States | Investigational Site Number :8400004 | Portland | Oregon |
| United States | Investigational Site Number :8400035 | Portland | Oregon |
| United States | Investigational Site Number :8400009 | Richmond | Virginia |
| United States | Investigational Site Number :8400005 | Sacramento | California |
| United States | Investigational Site Number :8400026 | Salt Lake City | Utah |
| United States | Investigational Site Number :8400021 | Syracuse | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Sanofi |
United States, Chile,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of participants achieving two consecutive =30% reductions in iPTH | Baseline up to Week 12 | ||
| Secondary | Percentage change from baseline in iPTH | Baseline, Week 12, Week 24 | ||
| Secondary | Number of hypercalcemia events (albumin corrected serum calcium >10.2 mg/dL) | Up to Weeks 12 and 24 | ||
| Secondary | Number of participants with adverse events | Baseline up to Week 24 | ||
| Secondary | Assessment of pharmacokinetic (PK) parameter: Serum 1,25-dihydroxyvitamin D2 concentration-time data | At Week -2, Baseline, and then within 24 hours of the most recent dose of Hectorol® at Weeks 2, 4, 6, 8 or 10 (whichever week is not used for serial PK assessment), and 12 |