DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Oral Calcitriol for Reduction of Mild Proteinuria in Patients With CKD

Information source: Huashan Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Kidney Disease; Proteinuria

Intervention: Calcitriol (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Huashan Hospital

Official(s) and/or principal investigator(s):
Jing Chen, M.D. PhD, Principal Investigator, Affiliation: Division of Nephrology, Huashan Hospital, Fudan University

Overall contact:
Jing Chen, M.D. PhD, Phone: 86-21-52889387, Email: chenjing1998@fudan.edu.cn

Summary

The safety and efficacy of Caltriol on mild proteinuria (<1. 0g/d) reduction in CKD patients.

Clinical Details

Official title: Phase 4 Study of Oral Calcitriol for Reduction of Mild Proteinuria in Patients With CKD

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: the percentage change of proteinuia

Secondary outcome: the proportion of patients achieving at least a 15% decrease in proteinuria

Detailed description: Proteinuria is not only a capital sign of kidney disease, but also a marker of chronic kidney disease (CKD) progression. Emerging evidence in patients with CKD show that vitamin D and its analogs can reduce proteinuria or albuminuria in the presence of angiotensin-converting enzyme inhibithion. While some of the studies reported that vitamin D receptor activation has been associated with increased serum creatinine and reduced estimated glomerular filtration rates. Therefore, the investigators plan to conduct a randomized clinical study to evaluate the efficacy and safety of Calcitriol in the treatment of mild proteinuria (<1. 0g/d) CKD patients,which has no specific treatment at present.

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- aged 18-75 years

- clinical diagnosed and/or biopsy-confirmed primary glomerulonephritis

- proteinuria 0. 15-1. 0 g/d in 2 consecutive samples within 4 weeks despite ACE

inhibitor (ACEI) or angiotensin receptor blocker (ARB) treatment for at least 1 year or ACEI/ARB withdrawal because of of drug intolerances (low blood pressure, cough, hyperkalemia) for at least 1 month

- estimated glomerular filtration rate (eGFR)>60ml/min/1/73m2

- corticosteroid and immunosuppressive agents withdrawal for at least 6 months

- normal blood pressure

- serum intact parathyroid hormone (iPTH) level >20pg/mL

- corrected serum calcium level < or = 2. 55 mmol/L

- serum phosphorus level < or = 1. 68 mmol/L

- 24 hours urinary calcium excretion level < or = 7. 5 mmol

- not receive treatment of vitamin D or its analogue within 6 months

- willigness to give written consent and comply with the study protocol

Exclusion Criteria:

- history of sensitivity or allergy to calcitriol or other vitamin D analogs

- pregnancy, lactating women

- history of severe coexisting disease such as, but not limited to, chronic liver

disease, myocardial infarction, cerebrovascular accident, malignant hypertension

- history of malignancy

- history of extraskeletal calcification, hyperuricemia, gout, kidney stone, gall

stone, bone diseases

- patients receiving drugs contains of calcium

- patients receiving cimetidine, trimethoprim, or other drugs which can increase

tubular creatinine reabsorption

- participation in any other trials within 1 month

- history of non-compliance

Locations and Contacts

Jing Chen, M.D. PhD, Phone: 86-21-52889387, Email: chenjing1998@fudan.edu.cn

Huashan Hospital, Fudan University, Shanghai, Shanghai 200040, China; Not yet recruiting
Li You, M.D. PhD, Phone: 86-21-52888133, Email: youlizzy@gmail.com
Additional Information

Starting date: March 2013
Last updated: March 28, 2013

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017