## Protocol Section
### Identification Module
**NCT ID:** NCT00796679

**Brief Title:** Oral Paricalcitol in Stage 3 - 5 Chronic Kidney Disease

**Official Title:** A Prospective, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy of Oral Paricalcitol in Retarding Cardiac Hypertrophy, Reducing Inflammation and Atherosclerosis in Stage 3 - 5 Chronic Kidney Disease

#### Organization Study ID Info
**ID:** A10-003
#### Organization
**Class:** OTHER
**Full Name:** The University of Hong Kong
### Status Module
#### Completion Date
**Date:** 2011-06

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-01-10

**Type:** ESTIMATED

**Last Update Submit Date:** 2017-01-07

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2011-06

**Type:** ACTUAL

#### Start Date
**Date:** 2008-10

**Status Verified Date:** 2017-01

#### Study First Post Date
**Date:** 2008-11-24
**Type:** ESTIMATED
**Study First Submit Date:** 2008-11-20
**Study First Submit QC Date:** 2008-11-21
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Abbott

#### Lead Sponsor

**Class:** OTHER

**Name:** The University of Hong Kong

#### Responsible Party

**Investigator Affiliation:** The University of Hong Kong

**Investigator Full Name:** Dr. Angela Yee-Moon Wang

**Investigator Title:** Dr.

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The purpose of this study is to test the hypothesis that selective vitamin D receptor activation reduces left ventricular hypertrophy and ameliorates inflammation and atherosclerosis in stage 3 -5 chronic kidney disease.

**Detailed Description:** Cardiovascular disease is the leading cause of mortality and morbidity in patients with chronic kidney disease. According to a previous study, only 15.6% of the patients beginning dialysis therapy had a normal echocardiogram, with left ventricular hypertrophy, left ventricular dilatation and systolic dysfunction occurring in 40.7%, 28% and 15.6% of patients, respectively. In addition, these patients are at an accelerated risk of developing atherosclerosis. The Kidney Disease Outcome Quality Initiative guideline recently raised concerns of a high prevalence of vitamin D deficiency in chronic kidney disease patients not yet requiring dialysis treatment. In addition, very recent data suggested that vitamin D deficiency is an important predictor of mortality in end-stage renal disease patients. Furthermore, hemodialysis patients treated with paricalcitol, a selective vitamin D receptor activator, showed a significantly lower risk of cardiovascular death than those not receiving vitamin D therapy. A number of studies also showed positive benefit of vitamin D receptor activator treatment on regression of left ventricular hypertrophy in dialysis patients. However, there is so far no data in patients with stage 3 and 4 chronic kidney disease where a high prevalence of vitamin D deficiency and cardiac hypertrophy has been reported.

### Conditions Module

**Conditions:**

- Chronic Kidney Disease

**Keywords:**

- paricalcitol

- chronic kidney disease

- cardiac hypertrophy

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 60

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** paricalcitol

**Intervention Names:**

- Drug: paricalcitol

**Label:** 1

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** placebo

**Intervention Names:**

- Drug: paricalcitol

**Label:** 2

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 1

- 2

**Description:** oral paricalcitol capsule 1 microgram once daily if iPTH \<500pg/mL or 2 microgram once daily if iPTH \>=500pg/mL. Thereafter, dose titration in 1 microgram decrement will be done based on safety reasons (that is, for low PTH or high calcium and phosphorus level). The duration of treatment will be for 1 year.

**Name:** paricalcitol

**Other Names:**

- Zemplar

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Change in left ventricular mass index determined by MRI

**Time Frame:** 1 year

#### Secondary Outcomes

**Measure:** Change in left atrial and ventricular volumes, systolic and diastolic function, carotid intima-media thickness, flow mediated dilation, pulse wave velocity, serum inflammatory and cardiac biomarkers, intact PTH, 24-hour urine protein and renal function

**Time Frame:** 1 year

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patient with stage 3 -5 chronic kidney disease (that is, eGFR \< 60 ml/min per 1.73m2) diagnosed for more than 2 months and not expected to start dialysis within the next 12 months, and
* Patient with screening echocardiography showing evidence of left ventricular hypertrophy
* Patient has not received vitamin D therapy in the previous 4 weeks
* For entry into the Treatment Phase, the subject must have:

  * screening iPTH \>= 55 pg/ml or 5.8pmol/L (determined by the Nichols second-generation assay or similar assay)
  * serum calcium \< 10.2 mg/dL (2.55 mmol/L)
  * serum phosphorus =\< 5.2mg/dL (1.68mmol/L)
  * Ca\*P product \< 54 mg2/dL2 (4.36mmol2/L2)
  * If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), or is of childbearing potential and practicing birth control measures.
* Patients who provide informed consent for the study

Exclusion Criteria:

* Patient with a history of an allergic reaction or significant sensitivity to vitamin D or vitamin D related compounds.
* Patient with history of renal stones
* Patient with current malignancy
* Patients with clinically significant gastrointestinal disease or liver disease
* Patient with acute renal failure in the recent three months
* Patient with a history of drug or alcohol abuse within six months prior to the screening phase
* Patient is known to be human immunodeficiency virus (HIV) positive.
* Patient with evidence of poor compliance with diet and medication.
* Patient currently receiving medications that may affect calcium, phosphorus metabolism such as calcitonin, cinacalcet, bisphophonates or vitamin D compounds (other than study drug), or other drugs that may affect calcium or bone metabolism, other than females on stable estrogen and/or progestin therapy.
* Patients with active granulomatous disease
* Patient with pregnancy
* Patients currently receiving glucocorticoid steroid or other immunosuppressive treatment or had been administered glucocorticoid or other immunosuppressive treatment for more than 14 days within recent 6 months.
* Patients with contraindication for MRI examination

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Hong Kong

**Country:** Hong Kong

**Facility:** Queen Mary Hospital

**Zip:** 0000

**Location 2:**

**City:** Hong Kong

**Country:** Hong Kong

**Facility:** University of Hong Kong, Queen Mary Hospital

**Zip:** 0000

#### Overall Officials

**Official 1:**

**Affiliation:** Queen Mary Hospital, University of Hong Kong

**Name:** Angela YM Wang, MD, FRCP

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Wang AY, Fang F, Chan J, Wen YY, Qing S, Chan IH, Lo G, Lai KN, Lo WK, Lam CW, Yu CM. Effect of paricalcitol on left ventricular mass and function in CKD--the OPERA trial. J Am Soc Nephrol. 2014 Jan;25(1):175-86. doi: 10.1681/ASN.2013010103. Epub 2013 Sep 19. Erratum In: J Am Soc Nephrol. 2019 Mar;30(3):516.

**PMID:** 24052631

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014570

- Term: Urologic Diseases

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

- ID: D000051437

- Term: Renal Insufficiency

- ID: D000002908

- Term: Chronic Disease

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10293

- Name: Inflammation

- Relevance: LOW

- As Found: Unknown

- ID: M10698

- Name: Kidney Diseases

- Relevance: HIGH

- As Found: Kidney Disease

- ID: M26188

- Name: Atherosclerosis

- Relevance: LOW

- As Found: Unknown

- ID: M10035

- Name: Hypertrophy

- Relevance: LOW

- As Found: Unknown

- ID: M26717

- Name: Renal Insufficiency, Chronic

- Relevance: HIGH

- As Found: Chronic Kidney Disease

- ID: M26718

- Name: Renal Insufficiency

- Relevance: LOW

- As Found: Unknown

- ID: M17319

- Name: Urologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6147

- Name: Chronic Disease

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: HIGH

- As Found: Chronic

### Condition Browse Module - Meshes

- ID: D000007674

- Term: Kidney Diseases

- ID: D000051436

- Term: Renal Insufficiency, Chronic

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: BDCA

- Name: Bone Density Conservation Agents

### Intervention Browse Module - Browse Leaves

- ID: M5381

- Name: Calcium

- Relevance: LOW

- As Found: Unknown

- ID: M5398

- Name: Calcium, Dietary

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
