A Multicenter, Open-Label Study of Hectorol (doxercalciferol capsules) for the Treatment of Secondary Hyperparathyroidism in Stage 3 or Stage 4 Chronic Kidney Disease (CKD) Patients

• Conditions: Secondary hyperparathyroidism in Stage 3 or Stage 4 Chronic Kidney Disease; MedDRA version: 9.1Level: LLTClassification code 10020708Term: Hyperparathyroidism secondary

• Registration Number: EUCTR2007-001043-22-DE
• Lead Sponsor: Genzyme Europe BV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09-11
• Last Update Posted: 31 July 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1.Male or female, aged 18 years or older.

2.CKD Stage 3 or 4, defined as glomerular filtration rate (GFR) from the abbreviated Modification of Diet in Renal Disease (MDRD) equation between 30 and 59 mL/min/1.73m2 for CKD Stage 3 or between 15 and 29 mL/min/1.73m2 for CKD Stage 4 at the Screening Visit.

3.iPTH > 70 pg/mL (> 7.7 pmol/L) for CKD Stage 3 or > 110 pg/mL (> 12.1 pmol/L) for CKD Stage 4, but < 700 pg/mL (< 77 pmol/L) at Week –1.

4.In the opinion of the Investigator, the patient is willing and able to maintain compliance with phosphate binder therapy (if applicable) throughout the study duration.

5.Willing and able to stop any prior active vitamin D therapy (e.g. alfacalcidiol, calcitriol, or paricalcitol) and/or calcimimetic for 28 days prior to Week –1 and maintain this throughout the study.

6.Willing and able to sign and date an Informed Consent form.

7.The patient, if of childbearing potential, must be willing to use an effective contraceptive method throughout the study, which includes barrier methods, hormones, or intrauterine devices.

8.A level of understanding and willingness to cooperate with all visits and procedures as described by the study personnel.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Intact PTH value > 700 pg/mL (> 77.0 pmol/L) at the Week -1 Visit.

2.Corrected serum calcium > 10.0 mg/dL (> 2.5 mmol/L) at Week –1.

3.Serum phosphorus > 5.0 mg/dL (> 1.61 mmol/L) at Week –1.

4.In the opinion of the Investigator, the patient currently has poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, human immunodeficiency virus infection, or any other clinically significant, unstable medical condition.

5.Abnormal liver function as measured by alanine aminotransferase (ALT)/aspartate aminotransferase (AST) greater than three times the upper limit of normal at the Screening Visit.

6.Deemed by the Investigator to have rapidly deteriorating renal function.

7.Spot urine calcium/creatinine ratio > 0.2 at Week –1.

8.Current malabsorption, severe chronic diarrhea, or ileostomy.

9.Any evidence of active malignancy except for basal cell carcinoma of the skin. A history of malignancy is not an exclusion criterion.

10.Allergic reaction to a drug which, in the opinion of the Investigator, suggests an increased potential for hypersensitivity to vitamin D therapy.

11.Active ethanol or drug abuse, excluding tobacco use.

12.Current use of aluminum or magnesium based binders.

13.Pregnant or breast-feeding women.

14.Anticipated dialysis or planned renal transplant less than 12 months from Week 0.

15.Treatment with an investigational drug during 30 days preceding the start of screening.

16.Prior renal transplant.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified