Optimizing Treatment Programs for Chronic Kidney Disease-mineral and Bone Disorder and Malnutrition

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2016-12-31

Brief Summary

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Multi-center, prospective, randomized, controlled study to verify the clinical effectiveness of K / DOQI guidelines. The efficiency and safety of Vitamin D2 and low protein diet treatment for prevention and treatment of CKD-MBD and malnutrition in CKD3-5 (ND) patients.

Detailed Description

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This study will enroll chronic kidney disease patients, stage 3 to 5ND, who have chronic kidney disease mineral and bone disease (CKD-MBD) and malnutrition as defined by Kidney Disease Improvement Global Outcome (KDIGO) Guidelines. Patients in five centers will be randomized. A total of 600 patients will be enrolled, 150 patients receiving Vitamin D2 treatment virus 150 patients receiving calcitriol treatment, and another 150 patients receiving low protein diet virus 150 patients receiving normal protein diet. Outcomes will be assessed as proportion of patients achieving target blood levels on calcium, phosphorus, parathyroid hormone, 25 hydroxyvitamin D, albumin and hemoglobin. Other outcomes will also be assessed, which include secondary hyperparathyroidism (sHPT), vascular calcification, cardiovascular diseases, nutritional status and quality of life.

Conditions

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Vitamin D Deficiency Malnutrition

Keywords

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chronic kidney disease mineral and bone disease Malnutrition Vitamin D low protein diet

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vitamin D2 Treatment

Group Type EXPERIMENTAL

Vitamin D2

Intervention Type DRUG

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.

1,25(OH)2 Vitamin D3

Group Type ACTIVE_COMPARATOR

1,25(OH)2 Vitamin D3

Intervention Type DRUG

Oral 1,25(OH)2 Vitamin D3 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.

low protein diet

Group Type EXPERIMENTAL

low protein diet

Intervention Type DIETARY_SUPPLEMENT

Using nutritious software to make meals recipes and give dietary guidance for patients to reach the DPI goal of 0.6g-0.8g/kg/d.

normal protein diet

Group Type ACTIVE_COMPARATOR

normal protein diet

Intervention Type DIETARY_SUPPLEMENT

Using nutritious software to make meals recipes and give dietary guidance for patients to reach the DPI goal of more than 0.8g/kg/d.

Interventions

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1,25(OH)2 Vitamin D3

Oral 1,25(OH)2 Vitamin D3 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.

Intervention Type DRUG

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.

Intervention Type DRUG

low protein diet

Using nutritious software to make meals recipes and give dietary guidance for patients to reach the DPI goal of 0.6g-0.8g/kg/d.

Intervention Type DIETARY_SUPPLEMENT

normal protein diet

Using nutritious software to make meals recipes and give dietary guidance for patients to reach the DPI goal of more than 0.8g/kg/d.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Active Vit D3 Vit D2

Eligibility Criteria

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Inclusion Criteria

* Patients with age between 18-80 years.
* Patients with chronic kidney disease stage 3 to 5, and concurrent chronic kidney disease mineral and bone disorder and malnutrition

Exclusion Criteria

* Renal artery stenosis, inherent renal malformation, solitary kidney, or malignancy in urinary system.
* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Wenhu Liu

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Wenhu Liu, Doctor

Role: PRINCIPAL_INVESTIGATOR

Nephrology Department of Beijing Friendship Hospita

Locations

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