Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-01-26 @ 1:39 AM
Study NCT ID:
NCT02005302
Status:
UNKNOWN
Last Update Posted:
2013-12-09
First Post:
2013-12-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimizing Treatment Programs for Chronic Kidney Disease-mineral and Bone Disorder and Malnutrition
Sponsor:
Wenhu Liu
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2013-12
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| D131100004713001 | OTHER_GRANT | Beijing Municipal Science and Technology Commission | View |