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

Wenhu Liu

Status and phase: Unknown; Phase 4

Conditions: Malnutrition; Vitamin D Deficiency

Treatments: Dietary Supplement: normal protein diet; Drug: 1,25(OH)2 Vitamin D3; Dietary Supplement: low protein diet; Drug: Vitamin D2

Study type: Interventional

Funder types: Other

Identifiers

NCT02005302

BJFH-EC/2013-076

D131100004713001 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 4 patient groups

Vitamin D2 Treatment

Experimental group

Treatment:

Drug: Vitamin D2

1,25(OH)2 Vitamin D3

Active Comparator group

Treatment:

Drug: 1,25(OH)2 Vitamin D3

low protein diet

Experimental group

Treatment:

Dietary Supplement: low protein diet

normal protein diet

Active Comparator group

Treatment:

Dietary Supplement: normal protein diet