Safety and Efficacy of CTAP101 to Treat Secondary Hyperparathyroidism in Stage 3 or 4 CKD and Vitamin D Insufficiency

NCT01651000 | Completed Phase 3 Results DMC

• 1 other identifier: CTAP101-CL-3001
• Study Type: interventional
• Target: 213
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the efficacy of CTAP101 Capsules versus placebo in reducing intact parathyroid hormone (iPTH) by at least 30% from pretreatment baseline; safety and tolerability of CTAP101 will also be evaluated

Conditions

Chronic Kidney Disease; Hyperparathyroidism, Secondary; Vitamin D Deficiency

Keywords

Parathyroid Diseases; Renal Insufficiency; Kidney Failure, Chronic; Hyperparathyroidism, Secondary; Vitamin D; Hyperparathyroidism; Kidney Diseases; Kidney Failure; Renal Insufficiency, Chronic

Outcome Measures

Primary Outcomes (1)

• Number of Participants in the Intent to Treat Population With Decrease in Plasma Intact Parathyroid Hormone (iPTH) of ≥30% From Pre-treatment Baseline Values

  Number of subjects in the intent to treat population attaining a mean decrease in plasma intact parathyroid hormone (iPTH) of ≥30% from pre-treatment baseline in the efficacy assessment phase (EAP), referred to as responders.

  Approximately 6 months

Secondary Outcomes (3)

• Number of Participants in the Per Protocol Population With Decrease in Plasma Intact Parathyroid Hormone (iPTH) of ≥30% From Pre-treatment Baseline Values

  Approximately 6 months

• Subjects in the Intent to Treat Population With Normal Serum Total 25-hydroxyvitamin D

  Approximately 6 months

• Subjects in the Per Protocol Population With Normal Serum Total 25-hydroxyvitamin D

  Approximately 6 months

Study Arms (2)

CTAP101 30 μg capsules

ACTIVE COMPARATOR

1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.

Drug: CTAP101 30 μg capsules; Other: Sugar pill to CTAP101 30 μg capsules

Sugar pill to CTAP101 30 μg capsule

PLACEBO COMPARATOR

1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.

Other: Sugar pill to CTAP101 30 μg capsules

Interventions

CTAP101 30 μg capsules DRUG

CTAP101 30 μg capsule taken daily at bedtime.

Also known as: Calcifediol

CTAP101 30 μg capsules

Sugar pill to CTAP101 30 μg capsules OTHER

Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.

Also known as: Placebo

CTAP101 30 μg capsules; Sugar pill to CTAP101 30 μg capsule

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Urinary albumin excretion ≤ 3000 mcg/mg of creatinine
• Stage 3 or 4 CKD
• Plasma iPTH: ≥ 85 pg/mL and \< 500 pg/mL
• Serum Ca: ≥ 8.4 mg/dL and \< 9.8 mg/dL
• Serum P: ≥ 2.0 mg/dL and \< 5.0 mg/dL
• Serum 25-hydroxyvitamin D: ≥ 10 ng/mL and \< 30 ng/mL.
• Stable dose of Vitamin D therapy ≤ 1600 IU/day and receiving same dose for at least 2 months

You may not qualify if:

• History of kidney transplant or parathyroidectomy
• Spot urine calcium:creatinine ratio \> 0.2 (\>200 mg/g Cr)
• Current serious illness, such as malignancy, HIV, liver disease, cardiovascular event or hepatitis
• Currently on dialysis
• Use of pharmacological dose of ergocalciferol or cholecalciferol (≥ 50,000 IU mcg per month) during the study

Sponsors & Collaborators

• OPKO IP Holdings II, Inc.: lead

Study Sites (1)

OPKO Renal

Bannockburn, Illinois, 60015, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hyperparathyroidism, Secondary; Vitamin D Deficiency; Parathyroid Diseases; Renal Insufficiency; Kidney Failure, Chronic; Hyperparathyroidism; Kidney Diseases

Interventions

Calcifediol; Sugars

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Endocrine System Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Hydroxycholecalciferols; Cholecalciferol; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Carbohydrates

Results Point of Contact

• Title: Douglass Laidlaw, PhD, Vice President, Medical Affairs
• Organization: OPKO Health, Inc.

dlaidlaw@opko.com

305-575-4172

Study Officials

• Joel Melnick, MD

  Opko Renal

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2012
• First Posted: July 26, 2012
• Study Start: September 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: January 13, 2025
• Results First Posted: August 17, 2016

Record last verified: 2019-12

Locations

US (1)