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

Phase 4

• Conditions: Vitamin D Deficiency; Malnutrition
• Interventions: Drug: 1,25(OH)2 Vitamin D3; Dietary Supplement: low protein diet; Dietary Supplement: normal protein diet; Drug: Vitamin D2

• Registration Number: NCT02005302
• Lead Sponsor: Wenhu Liu

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.

Study Timeline

• Study Start: 2013-01
• Status Verified: 2013-12
• Study First Submitted: 2013-12-04
• Study First Submitted QC: 2013-12-04
• Last Update Submitted: 2013-12-04
• Study First Posted: 2013-12-09
• Last Update Posted: 2013-12-09
• Primary Completion: 2015-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1,25(OH)2 Vitamin D3	1,25(OH)2 Vitamin D3	-
low protein diet	low protein diet	-
normal protein diet	normal protein diet	-
Vitamin D2 Treatment	Vitamin D2	-

Primary Outcome Measures

Name	Time	Method
The changes on the blood levels of calcium, phosphorus, and intact parathyroid (iPTH) hormone during 36 months	36 months	The blood levels of calcium, phosphorus,and intact parathyroid (iPTH) will be detected every three months. The values during follow-up will be compared to the baseline.
The changes on the clinical indicators of nutritional status	36 months	The blood levels of albumin, prealbumin, transferrin and hemoglobin will be detected every three months. The values during follow-up will be compared to the baseline.

Secondary Outcome Measures

Name	Time	Method
The changes of the blood 25(OH)Vitamin D level	36 months
The changes of the quality of life	36 months	Assess the quality of life for patients in accordance with KDQOL-SF scale every 6 month. The values during follow-up will be compared to the baseline.

Trial Locations

Locations (5)

Sino-Japanese Friendship Hospital; 🇨🇳 Beijing, Beijing, China

People's Liberation Army Air Force General Hospital; 🇨🇳 Beijing, Beijing, China

People's Liberation Army General Hospital; 🇨🇳 Beijing, Beijing, China

Beijing XuanWu Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Friedship Hospital; 🇨🇳 Beijing, Beijing, China