Trial Outcomes & Findings for Paricalcitol Compared to Maxacalcitol in Chronic Kidney Disease Patients With Secondary Hyperparathyroidism (NCT NCT00990704)

NCT ID: NCT00990704

Last Updated: 2011-07-11

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 47 participants
• Primary outcome timeframe: Baseline and the last 3 weeks (Weeks 11, 12, and 13)
• Results posted on: 2011-07-11

Participant Flow

Informed consent was obtained from 92 subjects; 45 of these subjects were not enrolled because they did not meet the eligibility criteria at the time of Screening.

Participant milestones

Measure	Paricalcitol 2 mcg with incremental of 1 mcg	Maxacalcitol 5 or 10 mcg with incremental of 2.5 mcg
Overall Study STARTED	14	33
Overall Study COMPLETED	13	31
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Measure	Paricalcitol 2 mcg with incremental of 1 mcg	Maxacalcitol 5 or 10 mcg with incremental of 2.5 mcg
Overall Study Adverse Event	1	1
Overall Study Physician Decision	0	1

Baseline Characteristics

Paricalcitol Compared to Maxacalcitol in Chronic Kidney Disease Patients With Secondary Hyperparathyroidism

Baseline characteristics by cohort

Measure	Paricalcitol n=14 Participants 2 mcg with incremental of 1 mcg	Maxacalcitol n=33 Participants 5 or 10 mcg with incremental of 2.5 mcg	Total n=47 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	19 Participants n=7 Participants	25 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants	14 Participants n=7 Participants	22 Participants n=5 Participants
Age Continuous	64.9 years STANDARD_DEVIATION 11.02 • n=5 Participants	61.5 years STANDARD_DEVIATION 9.73 • n=7 Participants	62.5 years STANDARD_DEVIATION 10.13 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	28 Participants n=7 Participants	38 Participants n=5 Participants
Region of Enrollment Japan	14 participants n=5 Participants	33 participants n=7 Participants	47 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and the last 3 weeks (Weeks 11, 12, and 13)

Population: All subjects who received at least 1 dose of study drug and who had at least 1 iPTH measurement while on treatment.

Outcome measures

Measure	Paricalcitol n=14 Participants 2 mcg with incremental of 1 mcg	Maxacalcitol n=33 Participants 5 or 10 mcg with incremental of 2.5 mcg
The Percentage of Participants With a >=50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline Compared to the Average iPTH Obtained in the Last 3 Weeks.	50.0 Percentage of participants	36.4 Percentage of participants

SECONDARY outcome

Timeframe: During the last 3 weeks (Weeks 11, 12, and 13)

Outcome measures

Measure	Paricalcitol n=14 Participants 2 mcg with incremental of 1 mcg	Maxacalcitol n=33 Participants 5 or 10 mcg with incremental of 2.5 mcg
The Percentage of Participants With iPTH Within Target Range of 60-180 pg/mL, Based on the Average iPTH Obtained in the Last 3 Weeks	28.6 Percentage of participants	15.2 Percentage of participants

SECONDARY outcome

Timeframe: Screening (up to 2 weeks before Baseline) to Week 13

Outcome measures

Measure	Paricalcitol n=14 Participants 2 mcg with incremental of 1 mcg	Maxacalcitol n=33 Participants 5 or 10 mcg with incremental of 2.5 mcg
Mean iPTH at Each Visit Week 6	304.8 pg/mL Standard Deviation 136.76	262.3 pg/mL Standard Deviation 144.72
Mean iPTH at Each Visit Week 7	282.2 pg/mL Standard Deviation 152.76	292.8 pg/mL Standard Deviation 187.02
Mean iPTH at Each Visit Week 8	256.9 pg/mL Standard Deviation 142.39	315.1 pg/mL Standard Deviation 229.53
Mean iPTH at Each Visit Screening (up to 2 weeks before Baseline)	462.7 pg/mL Standard Deviation 127.62	536.4 pg/mL Standard Deviation 190.72
Mean iPTH at Each Visit Baseline (Week 1)	507.6 pg/mL Standard Deviation 162.47	595.9 pg/mL Standard Deviation 213.80
Mean iPTH at Each Visit Week 2	479.2 pg/mL Standard Deviation 178.43	474.8 pg/mL Standard Deviation 201.00
Mean iPTH at Each Visit Week 3	474.4 pg/mL Standard Deviation 201.98	381.8 pg/mL Standard Deviation 181.07
Mean iPTH at Each Visit Week 4	401.3 pg/mL Standard Deviation 209.24	310.2 pg/mL Standard Deviation 158.68
Mean iPTH at Each Visit Week 5	373.2 pg/mL Standard Deviation 181.64	279.7 pg/mL Standard Deviation 155.07
Mean iPTH at Each Visit Week 9	275.9 pg/mL Standard Deviation 158.39	358.8 pg/mL Standard Deviation 252.98
Mean iPTH at Each Visit Week 10	312.6 pg/mL Standard Deviation 140.45	361.2 pg/mL Standard Deviation 228.37
Mean iPTH at Each Visit Week 11	279.6 pg/mL Standard Deviation 159.69	345.1 pg/mL Standard Deviation 189.52
Mean iPTH at Each Visit Week 12	291.5 pg/mL Standard Deviation 163.51	341.6 pg/mL Standard Deviation 192.65
Mean iPTH at Each Visit Week 13	293.0 pg/mL Standard Deviation 164.74	326.4 pg/mL Standard Deviation 180.33

SECONDARY outcome

Timeframe: Baseline and the last 3 weeks (Weeks 11, 12, and 13)

Outcome measures

Measure	Paricalcitol n=14 Participants 2 mcg with incremental of 1 mcg	Maxacalcitol n=33 Participants 5 or 10 mcg with incremental of 2.5 mcg
Mean Change in iPTH From Baseline to the Average iPTH Obtained in the Last 3 Weeks	-208.4 pg/mL Standard Deviation 136.70	-240.4 pg/mL Standard Deviation 152.73

SECONDARY outcome

Timeframe: Baseline and the last 3 weeks (Weeks 11, 12, and 13) for iPTH and anytime during the 12-week treatment period for hypercalcemia

Hypercalcemia was defined as at least 1 corrected calcium > 11.5 mg/dL or at least 2 consecutive corrected calcium >= 11.0 mg/dL.

Outcome measures

Measure	Paricalcitol n=14 Participants 2 mcg with incremental of 1 mcg	Maxacalcitol n=33 Participants 5 or 10 mcg with incremental of 2.5 mcg
Percentage of Participants With a >= 50% Reduction in iPTH From Baseline to the Average iPTH Obtained in the Last 3 Weeks and Without Hypercalcemia During Treatment	50.0 Percentage of participants	33.3 Percentage of participants

SECONDARY outcome

Timeframe: Baseline and the last 3 weeks (Weeks 11, 12, and 13) for iPTH and anytime during the 12-week treatment period for hypercalcemia

Hypercalcemia was defined as at least 1 corrected calcium > 11.5 mg/dL or at least 2 consecutive corrected calcium >= 11.0 mg/dL.

Outcome measures

Measure	Paricalcitol n=14 Participants 2 mcg with incremental of 1 mcg	Maxacalcitol n=33 Participants 5 or 10 mcg with incremental of 2.5 mcg
Percentage of Participants With iPTH Within the Target Range of 60-180 pg/mL Based on the Average iPTH Obtained in the Last 3 Weeks of the Study and Without Hypercalcemia Anytime During Treatment	28.6 Percentage of participants	12.1 Percentage of participants

SECONDARY outcome

Timeframe: Over the 12-week treatment period

Outcome measures

Measure	Paricalcitol n=14 Participants 2 mcg with incremental of 1 mcg	Maxacalcitol n=33 Participants 5 or 10 mcg with incremental of 2.5 mcg
Number of Occurrences of iPTH Control, Defined as >=50% Reduction in iPTH From Baseline	3.4 Occurrences per participant Standard Deviation 2.98	4.8 Occurrences per participant Standard Deviation 2.96

SECONDARY outcome

Timeframe: Over the 12-week treatment period

Outcome measures

Measure	Paricalcitol n=14 Participants 2 mcg with incremental of 1 mcg	Maxacalcitol n=33 Participants 5 or 10 mcg with incremental of 2.5 mcg
Number of Occurrences of iPTH Control, Defined as Within the Target Range of 60-180 pg/mL of iPTH	2.3 Occurrences per participant Standard Deviation 2.70	2.7 Occurrences per participant Standard Deviation 2.67

Adverse Events

Paricalcitol

Serious events: 3 serious events

Other events: 14 other events

Deaths: 0 deaths

Maxacalcitol

Serious events: 3 serious events

Other events: 31 other events

Deaths: 0 deaths

Serious adverse events

Measure	Paricalcitol n=14 participants at risk 2 mcg with incremental of 1 mcg	Maxacalcitol n=33 participants at risk 5 or 10 mcg with incremental of 2.5 mcg
Eye disorders Cataract	7.1% 1/14	0.00% 0/33
Eye disorders Vitreous haemorrhage	7.1% 1/14	0.00% 0/33
Injury, poisoning and procedural complications Pyothorax	7.1% 1/14	0.00% 0/33
Skin and subcutaneous tissue disorders Skin papilloma	7.1% 1/14	0.00% 0/33
Cardiac disorders Supraventricular tachycardia	0.00% 0/14	3.0% 1/33
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/14	3.0% 1/33
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/14	3.0% 1/33

Other adverse events

Measure	Paricalcitol n=14 participants at risk 2 mcg with incremental of 1 mcg	Maxacalcitol n=33 participants at risk 5 or 10 mcg with incremental of 2.5 mcg
Eye disorders Eye pruritus	7.1% 1/14	0.00% 0/33
Eye disorders Scleritis	7.1% 1/14	0.00% 0/33
Gastrointestinal disorders Constipation	7.1% 1/14	6.1% 2/33
Gastrointestinal disorders Gastritis	7.1% 1/14	3.0% 1/33
Gastrointestinal disorders Gingivitis	14.3% 2/14	0.00% 0/33
Gastrointestinal disorders Nausea	0.00% 0/14	6.1% 2/33
Gastrointestinal disorders Stomach discomfort	0.00% 0/14	6.1% 2/33
General disorders Injection site dermatitis	7.1% 1/14	0.00% 0/33
Hepatobiliary disorders Hepatic function abnormal	7.1% 1/14	0.00% 0/33
Infections and infestations Nasopharyngitis	42.9% 6/14	36.4% 12/33
Infections and infestations Upper respiratory tract infection	7.1% 1/14	3.0% 1/33
Injury, poisoning and procedural complications Contusion	0.00% 0/14	6.1% 2/33
Injury, poisoning and procedural complications Excoriation	0.00% 0/14	6.1% 2/33
Injury, poisoning and procedural complications Fall	0.00% 0/14	6.1% 2/33
Injury, poisoning and procedural complications Procedural hypotension	14.3% 2/14	12.1% 4/33
Injury, poisoning and procedural complications Shunt stenosis	7.1% 1/14	3.0% 1/33
Injury, poisoning and procedural complications Wound	14.3% 2/14	3.0% 1/33
Investigations Blood pressure decreased	7.1% 1/14	0.00% 0/33
Investigations Serum ferritin increased	7.1% 1/14	0.00% 0/33
Metabolism and nutrition disorders Hypercalcaemia	7.1% 1/14	36.4% 12/33
Metabolism and nutrition disorders Hyperkalaemia	14.3% 2/14	3.0% 1/33
Metabolism and nutrition disorders Hyperphosphataemia	35.7% 5/14	33.3% 11/33
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/14	6.1% 2/33
Musculoskeletal and connective tissue disorders Musculoskeletal pain	7.1% 1/14	0.00% 0/33
Nervous system disorders Headache	7.1% 1/14	0.00% 0/33
Nervous system disorders Hypoaesthesia	7.1% 1/14	0.00% 0/33
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	0.00% 0/14	6.1% 2/33
Skin and subcutaneous tissue disorders Haemorrhage subcutaneous	7.1% 1/14	3.0% 1/33
Skin and subcutaneous tissue disorders Hyperkeratosis	0.00% 0/14	9.1% 3/33
Skin and subcutaneous tissue disorders Pruritus	7.1% 1/14	6.1% 2/33
Skin and subcutaneous tissue disorders Skin chapped	7.1% 1/14	0.00% 0/33
Skin and subcutaneous tissue disorders Skin exfoliation	7.1% 1/14	6.1% 2/33
Vascular disorders Hypertension	14.3% 2/14	9.1% 3/33

Additional Information

Global Medical Services

Abbott

Phone: 800-633-9110

Results disclosure agreements

• Principal investigator is a sponsor employee Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
• Publication restrictions are in place

Restriction type: OTHER