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
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