Phase 4 N=204 Randomized Treatment

Efficacy of Vitamin D2 to Treat Chronic Kidney Disease Mineral and Bone Disorder

Vitamin D Deficiency

Bottom Line

View on ClinicalTrials.gov: NCT01633853 ↗

Enrolled (actual)

204

Serious AEs

11.3%

Results posted

Feb 2016

Primary outcome: Primary: The Blood Levels of Calcium at the 24th Month of Following up. — 2.31; 2.33 mmol/L — p=0.117

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Vitamin D2 (Drug); 1,25(OH)2 Vit D3 (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Dongliang Zhang, MD
Primary completion: Sep 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY The Blood Levels of Calcium at the 24th Month of Following up.	2.31; 2.33	0.117
PRIMARY The Blood Levels of Phosphorus at the 24th Month of Following up.	1.27; 1.25	<0.001 sig
PRIMARY The Blood Levels of Intact Parathyroid Hormone at the 24th Month of Following up.	96.5; 108.1	0.179
SECONDARY The Blood 25(OH)Vitamin D Level.	37.31; 18.07	<0.001 sig
SECONDARY The Incidence Rate of Secondary Hyperparathyroidism.	14; 15	0.753

Summary

It is hypothesised that the efficacy and safety of Vitamin D2 soft capsule to treat the Chronic Kidney Disease Mineral and Bone Disease (CKD-MBD) are equal to 1,25(OH)2 Vitamin D3 (Rocaltrol) in the patients with CKD stage 3-5.

Eligibility Criteria

Inclusion Criteria

Patients with age between 18-75 years.
Patients with chronic kidney disease stage 3 to 5, and concurrent chronic kidney disease mineral and bone disorder.

Exclusion Criteria

Renal artery stenosis, inherent renal malformation, solitary kidney, or malignancy in urinary system.
New fracture in last 3 months.
Active system immunity diseases.
History of liver failure
History of intestinal malabsorption or chronic diarrhea
Treatment with phenobarbital, phenytoin, rifampicin, sucralfate, steroids, digoxin, or other medications that could affect vitamin D metabolism
Primary hyperparathyroidism
Treatment with cinacalcet or other calcimimetic within the past 6 months
Anticipated dialysis within 6 months after randomization
Have an unstable medical condition, defined as having been hospitalized within 30 days before screening, the expectation of recurrent hospital admissions or life expectancy of less than 6 months in the judgment of the investigator
Subject is currently enrolled in, or fewer than 30 days have passed since subject has completed another investigational device or drug study(s); or subject is receiving another investigational agent(s).
Current treatment with vitamin D 50, 000 IU
Using glucocorticoid or immunosuppressive agents.
Acute renal dysfunction.
The expected live time is less than 2 years.
Pregnant or lactating woman.
Suffered from acute myocardial infraction, acute congestive heart failure, or stroke in last 6 months.
Patients whose concurrent illnesses, disability, or geographical residence would hamper attendance at required study visit.

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Data sourced from ClinicalTrials.gov (NCT01633853). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.