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

NCT01633853 | Completed Phase 4 Results DMC

• 3 other identifiers: 2012-078Z1211070010121382011-2002-02
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vitamin D Deficiency

Keywords

chronic kidney disease mineral and bone disorder; vitamin D2; parathyroid hormone

Outcome Measures

Primary Outcomes (3)

• The Blood Levels of Calcium at the 24th Month of Following up.

  The blood levels of calcium at the 24th month of following up will be detected.

  24 months

• The Blood Levels of Phosphorus at the 24th Month of Following up.

  The blood levels of phosphorus at the 24th month of following up will be detected.

  24 months

• The Blood Levels of Intact Parathyroid Hormone at the 24th Month of Following up.

  The blood levels of intact parathyroid hormone (iPTH) at the 24th month of following up will be detected.

  24 months

Secondary Outcomes (2)

• The Blood 25(OH)Vitamin D Level.

  24 months

• The Incidence Rate of Secondary Hyperparathyroidism.

  24 months

Study Arms (2)

Vitamin D2 Treatment

EXPERIMENTAL

Patients will be treated by vitamin D2. Oral Vit D2 1.25mg(50,000 unit) once weekly as a start and maintain 1.25mg(50,000 unit) once monthly according to the blood 25(OH)vitamin D level.

Drug: Vitamin D2

1,25(OH)2 Vitamin D3

ACTIVE COMPARATOR

Patients will be treated by 1,25(OH)2 Vitamin D3. Oral 1,25(OH)2 Vitamin D3(Rocaltrol) by 0.25 microgram once daily at start and regulate the dose according to the changes of blood levels of 25(OH)Vit D, calcium, phosphorus, and intact parathyroid hormone.

Drug: 1,25(OH)2 Vit D3

Interventions

Vitamin D2 DRUG

Treatment with Vit D2.

Also known as: Vitamin D2 soft capsules

Vitamin D2 Treatment

1,25(OH)2 Vit D3 DRUG

Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol).

Also known as: Rocaltrol

1,25(OH)2 Vitamin D3

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dongliang Zhang, MD: lead
• Beijing Municipal Science & Technology Commission: collaborator

Study Sites (1)

Beijing Friedship Hospital

Beijing, Beijing Municipality, 100050, China

Location

MeSH Terms

Conditions

Vitamin D Deficiency; Chronic Kidney Disease-Mineral and Bone Disorder

Interventions

Ergocalciferols; Calcitriol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Rickets; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Metabolic Diseases; Calcium Metabolism Disorders; Hyperparathyroidism, Secondary; Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Zhang Dongliang
• Organization: Peking University Internetional Hospital

zhangdongliang@pkuih.edu.cn

+86-10-69006561

Study Officials

• Dongliang Zhang, Doctor

  Nephrology Department of Beijing Friendship Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 29, 2012
• First Posted: July 4, 2012
• Study Start: July 1, 2012
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: February 15, 2016
• Results First Posted: February 15, 2016

Record last verified: 2016-01

Locations

CN (1)