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Home » Trials » SLCTR/2014/007

Double blind randomized placebo controlled trial of corticosteroids and doxycycline in the treatment of interstitial nephritis

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SLCTR Registration Number

SLCTR/2014/007

Date of Registration

31 Mar 2014

The date of last modification

Mar 03, 2019

Trial Status


Application Summary

Scientific Title of Trial

Double blind randomized placebo controlled trial of corticosteroids and doxycycline in the treatment of interstitial nephritis

Public Title of Trial

Research on acute interstitial nephritis disease

Disease or Health Condition(s) Studied

Acute interstitial nephritis

Scientific Acronym

None

Public Acronym

None

Brief title

None

Universal Trial Number

None

Any other number(s) assigned to the trial and issuing authority

None


Trial Details

What is the research question being addressed?

To determine the effectiveness of corticosteroids and doxycycline (on their own and in combination) in the treatment of interstitial nephritis

Type of study

Interventional

Study design

Allocation

Randomized controlled trial

Masking

Double blinded

Control

Placebo

Assignment

Parallel

Purpose

Treatment

Study Phase

Not Available

Intervention(s) planned

Patients will be randomly categorized in to four groups by computer generated randomization sequence Each category will receive two drugs as follows, starting from the day after biopsy.

Category 1: steroid ( Prednesolone 1mg/kg/body weight tapering over three months) and placebo (Starch based tablet and caplsule filled with Glucose) Category 2: doxycycline (100mg bd for one month and placebo). Category 3: steroid and doxycycline Category 4: two placebos

Inclusion criteria

  1. Two or more elevated (value more than upper limit of the normal) serum creatinine values done within 3 days and
  2. Normal size kidneys defined as more than 9 cm longitudinal diameter and normal anatomy on ultrasound scan
  3. Age less than 60 years

Exclusion criteria

  1. History of chronic kidney disease, diabetes mellitus, chronic hypertension, connective tissue diseases, vacuities,hyperuricemia, pyelonephritis, renal stone disease and any obstructive uropathy, polycystic kidney disease or any other known genetic disease, glomerular nephritides, snake bite, and childhood renal disease.
  2. Whose current abnormal creatinine is explainable by recent exposure to nephrotoxic drugs (non-steroidal anti-inflammatory drugs, gentamicin…etc.) or toxins.
  3. BP >160/100mmhg untreated or >140/90 on up to two antihypertensives
  4. Two or more fasting blood sugar more than 7 mmol/l
  5. UFR showing red blood cells more 50 per HPF with more than 80% dysmorphic cells or nephrotic range proteinuria or pus cells more than 100 per HPF with a positive urine culture
  6. Ultrasound scan revealing unilateral renal involvement

Primary outcome(s)

1.

Serum creatinine

[

2 weeks, one month, six month, two years

]

Secondary outcome(s)

1.
  1. Reaching stage 4 kidney disease
  2. Death
  3. Small contracted kidneys
 [

6months, 2 years

]

Target number/sample size

200

Countries of recruitment

Sri Lanka

Anticipated start date

2014-04-01

Anticipated end date

2015-12-31

Date of first enrollment

2014-04-20

Date of study completion

Recruitment status

Terminated

Funding source

None

Regulatory approvals


State of Ethics Review Approval

Status

Approved

Date of Approval

2012-11-15

Approval number

2012/EC/54

Details of Ethics Review Committee

Name: 6. Ethics Review Committee, Faculty of Medicine, University of Peradeniya
Institutional Address:
Telephone:+94-812396361
Email: chairpersonierc@gmail.com

Contact & Sponsor Information

Contact person for Scientific Queries/Principal Investigator

Nishantha Nanayakkara
Consultant Nephrologist
Teaching hospital, Kandy
0812233337
0714964313

nishansrikandy@yahoo.co.in
no

Contact Person for Public Queries

Gayan Liyanage
Research assisstant
Nephrology and Transplant Unit, Teaching Hospital, Kandy
0812233337
0777779377
0812200405
pamuditha777@gmail.com
no

Primary study sponsor/organization

None





Secondary study sponsor (If any)

None





Trial Completion details

Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

IPD sharing plan description

Study protocol available

Protocol version and date

Not Available

Protocol URL

Not Available

Results summary available

No

Date of posting results

Date of study completion

Final sample size

Date of first publication

Link to results

Brief summary of results


  • Trial Options