| CTRI Number |
CTRI/2010/091/000298 [Registered on: 27/04/2010] |
| Last Modified On: |
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| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
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Public Title of Study
|
Placebo Versus SBR759 in Lowering Phosphate in Dialysis Patients |
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Scientific Title of Study
|
A Double-blind, Randomized, Placebo-controlled Multi-center Trial to Compare the Phosphate Lowering Efficacy of Different Doses of SBR759 to Placebo |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| CSBR759A2304 |
Protocol Number |
| NCT01069692 |
ClinicalTrials.gov |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
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| Designation |
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| Affiliation |
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| Address |
Not Applicable
N/A
India |
| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
|
| Name |
Dr. Kamala Rai |
| Designation |
|
| Affiliation |
|
| Address |
Novartis Healthcare Private Limited, Medical Department, Sandoz House,
Shiv Sagar Estate, Dr. Annie Besant Road, Worli,
Mumbai
MAHARASHTRA
400 018
India |
| Phone |
022 -24958533 |
| Fax |
022 -24954112 |
| Email |
kamala.rai@novartis.com |
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Details of Contact Person
Public Query
|
| Name |
Dr. Kamala Rai |
| Designation |
|
| Affiliation |
|
| Address |
Novartis Healthcare Private Limited, Medical Department, Sandoz House,
Shiv Sagar Estate, Dr. Annie Besant Road, Worli,
Mumbai
MAHARASHTRA
400 018
India |
| Phone |
022 -24958533 |
| Fax |
022 -24954112 |
| Email |
kamala.rai@novartis.com |
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Source of Monetary or Material Support
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| Novartis Pharma AG, Basel, Switzerland |
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Primary Sponsor
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| Name |
Novartis |
| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Bharat Shah |
Anil Clinic |
B-4, Shilpa Apartment, Dr. CharatSingh Colony,AG Link Road, Chakala, Andheri East -400093
Mumbai
MAHARASHTRA |
91-22-28368634
91-22-26452856
dr_bharatvshah@yahoo.co.in |
| Dr. Santosh Varghese |
Christian Medical College |
Dept. of Nephrology,-632004
Vellore
TAMIL NADU |
0416 2282053
santosh.vellore@gmail.com |
| Dr. Sundar S |
Columbia Asia Referral Hospital - Yeshwanthpur |
#26/1, Brigade Gateway, Beside Metro,,Malleshwaram West,-560 055
Bangalore
KARNATAKA |
|
| Dr. Satish Balan |
Health And Research Centre |
T.C. 1/907, Ist floor- Devi Scans Building,Kumarapuram, Medical College P.O. -695 011
|
91-4712554911
0471-2554913
healthtrials@gmail.com |
| Dr. Umesh Khanna |
Lancelot Kidney & GI Center |
111-C, Lancelot, ,S.V. Road, Borivli (W)-400092
Mumbai
MAHARASHTRA |
91-22-28016266
mu_khanna@yahoo.co.in |
| Dr. R. Ravichandran |
Madras Institute of Nephrology Research Private Limited |
New No. 7 / Old No. 23,, III Main Road, Kottur Gardens-600085
Chennai
TAMIL NADU |
91-44-2249 3440
91-44-22494440
ravidoc55@yahoo.co.in |
| Dr. Georgi Abrahm |
Madras Medical Mission |
Chennai Transplant Center,,4-A, Dr. J Jyalalitha Nagar, Mogappair, -600037
Chennai
TAMIL NADU |
91-44-2656 2800
044 2656 5961
abraham_georgi@yahoo.com |
| Dr. Sishir Gang |
Muljibhai Patel Urological Hospital |
Consultant Nephrologist,,-387001
|
91-268-2520325
sishirgang@hotmail.com |
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Details of Ethics Committee
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| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| Ethics Committee at Christian Medical College |
Submittted/Under Review |
| Ethics Committee, MIOT Hospitals (MIOT Institute of Nephrology) |
Approved |
| Ethics Committee, Muljibhai Patel Urological Hospital, |
Approved |
| Independent Human Ethics Committee, HRC |
Approved |
| Institutional Ethics Committee, Columbia Asia Hospitals |
Approved |
| Institutional Ethics Committee, Madras Medical Mission |
Approved |
| Jagruti Independent Ethics Committee |
Approved |
| Jagruti Independent Ethics Committee |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
Hyperphosphatemia
Chronic Kidney Disease
, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo Comparator |
0g daily |
| Intervention |
SBR759A |
12g daily |
| Intervention |
SBR759A |
3g daily |
| Intervention |
SBR759A |
6g daily |
| Intervention |
SBR759A |
9g daily |
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Inclusion Criteria
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| Age From |
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| Age To |
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| Gender |
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| Details |
1. Men or women of at least 18 years of age
2. Stable maintenance of hemodialysis 3 times per week for 3 months or greater
3. Controlled serum phosphate if under phosphate-binder therapy
4. Patient must either be on a stable phosphate binder dose and are willing to stop their phosphate binder therapy at the beginning of the study, or not have received any phosphate binder therapy for at least 4 weeks prior to screening
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| ExclusionCriteria |
| Details |
1. Patients who are on peritoneal dialysis
2. Patients who have a transplant or parathyroidectomy scheduled during the study
3. Clinically significant GI disorder
4. Unstable medical condition other than Chronic Kidney Disease
5. Patient is currently being treated with oral iron
6. History of hemachromatosis, or ferritin > 1000 ng/mL
7. Transferrin saturation > 60%
8. Uncontrolled hyperparathyroidism (iPTH > 84.8 pmol/L) Other protocol-defined inclusion/exclusion criteria may apply
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Centralized |
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Blinding/Masking
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Participant, Investigator and Outcome Assessor Blinded |
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Primary Outcome
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| Outcome |
TimePoints |
| * Evaluate the change from baseline in 72-hour serum phosphate levels of 4 different doses of SBR759 versus placebo over 4 weeks of treatment |
6 weeks |
|
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Secondary Outcome
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| Outcome |
TimePoints |
| * Evaluate changes in serum phosphate during a 2 week random treatment withdrawal period of SBR759 after 4 weeks treatment |
6 weeks |
| * Evaluate dose-dependent efficacy of SBR759 |
6 weeks |
| * Compare the short-term safety profile and dose-dependent tolerability of SBR759 dosed with meals taken 3 times a day to that of placebo |
6 weeks |
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Target Sample Size
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Total Sample Size="290"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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Phase 3 |
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Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/02/2010 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
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Years="0"
Months="11"
Days="0" |
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Recruitment Status of Trial (Global)
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Other (Terminated) |
| Recruitment Status of Trial (India) |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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Target number of patients from India is 60.
Planned FPFV is 10th May 2010. |