Clinical trial NCT02005302: Optimizing Treatment Programs for Chronic Kidney Disease-mineral and Bone Disorder and Malnutrition
Official title: Study of Vitamin D2 Virus 1,25(OH)2-Vitamin D3 and Normal Protein Diet Virus Low Protein Diet in the Treatment of CKD-MBD and Malnutrition for Progressive CKD Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Vitamin D Deficiency
Malnutrition
Keywords: chronic kidney disease
mineral and bone disease
Malnutrition
Vitamin D
low protein diet
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Municipal Science & Technology Commission
First posted: 2013-12-09
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The changes on the blood levels of calcium, phosphorus, and intact parathyroid (iPTH) hormone during 36 months
timeFrame: 36 months
measure: The changes on the clinical indicators of nutritional status
timeFrame: 36 months
Secondary outcomes:
measure: The changes of the blood 25(OH)Vitamin D level
timeFrame: 36 months
measure: The changes of the quality of life
timeFrame: 36 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing XuanWu Hospital
state: Beijing
city: Beijing
country: China
facility: People's Liberation Army Air Force General Hospital
state: Beijing
city: Beijing
country: China
facility: People's Liberation Army General Hospital
state: Beijing
city: Beijing
country: China
facility: Sino-Japanese Friendship Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Friedship Hospital
state: Beijing
Study officials:
affiliation: Nephrology Department of Beijing Friendship Hospita
name: Wenhu Liu, Doctor
role: PRINCIPAL_INVESTIGATOR
References: