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| autoid | 111 |
| crg_id | CRG030600043 |
| titleoftrial | Efficacy of sevelamer versus calcium acetate in patients with chronic kidney disease stage3 and 4: An Open label, randomized study |
| acronymnoftrial | |
| website | http:// |
| identificationno | |
| leadprefix | Dr |
| leadsurname | Bagga |
| leadgivennames | Arvind |
| leadposition | Professor |
| leaddepartment | Division of Pediatric Nephrology, Pediatrics |
| leadorganisation | All India Institute of Medical Sciences |
| leadaddress | A.I.I.M.S., Ansari Nagar, New Delhi, India 110029 |
| leademail | arvindbagga@hotmail.com |
| leadphone | +91 11 26593472 |
| leadfax | +91 11 26588641 |
| leadsuffix | |
| contactprefix | |
| contactsurname | |
| contactgivennames | |
| contactposition | |
| contactdepartment | |
| contactorganisation | |
| contactaddress | |
| contactemail | |
| contactphone | |
| contactfax | |
| funding | other |
| otherfunding | No direct funding but study medication supplied to patients by the drug company. |
| fundingnameofsponsors | Emcure Pharmaceuticals Limited |
| ethicsapproval | yes |
| studytype | randomised |
| studytype_other | |
| groupassignment | parallel |
| blinding_patients | no |
| blinding_investigators | no |
| blinding_outcomes | no |
| blinding_analysts | no |
| proposedstart | Mar 2006 |
| actualstart | |
| proposedcompletiondate | Mar 2007 |
| actualcompletiondate | |
| multi_center_study | no |
| numberofcentres | |
| multi_national_study | no |
| countrycentres | India |
| researchquestion | To compare the efficacy of 12-weeks’ treatment with sevelamer hydrochloride and calcium acetate in patients, between the ages of 2 and 18 years, with CKD stage 3 and 4 |
| study_status_recruitment | not_yet_recruiting |
| study_status_recruitment_follow | |
| healthcarecondition | Chronic Kidney Disease Stages 3 and 4 |
| intervention1 | Therapy with either calcium acetate or sevelamer |
| intervention2 | |
| intervention3 | |
| intervention4 | |
| participants_gender | both |
| participants_other | children |
| age | 2-18 yrs |
| totalrecruitment | 20 |
| inclusion | a)Children between 2 and 18 years of age with CKD stage 3 and 4
b)Serum phosphate level > 5.5 and < 7.5 mg/dL c)Children whose parents provide informed consent |
| exclusion | a)Serum calcium level < 7.5 mg/dL; > 11 mg/dL |
| primaryoutcomes | To compare the efficacy of 12-weeks’ treatment with sevelamer hydrochloride and calcium acetate in patients, between the ages of 2 and 18 years, with CKD stage 3 and 4 |
| secondaryoutcomes | a) To determine the safety and tolerability of sevelamer and calcium acetate
b) To examine the effect of these agents on blood levels of calcium, bicarbonate, calcium-phosphate product, PTH and lipids |
| reference |