ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 59 of 25545 for:    Change in | Recruiting, Not yet recruiting, Available Studies

Tacrolimus Versus Prednisolone for the Treatment of Minimal Change Disease (MinTAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00982072
Recruitment Status : Recruiting
First Posted : September 22, 2009
Last Update Posted : March 6, 2017
Sponsor:
Information provided by (Responsible Party):
Imperial College Healthcare NHS Trust

Brief Summary:
The purpose of this study is to compare the effectiveness of tacrolimus (prograf) versus prednisolone for the treatment of nephrotic syndrome secondary to minimal change disease.

Condition or disease Intervention/treatment Phase
Minimal Change Disease Drug: tacrolimus Drug: prednisolone Phase 4

Detailed Description:

Minimal change disease is a common cause of nephrotic syndrome in adults. Standard treatment is with high dose steroids which is often effective in controlling the nephrotic syndrome but has a high morbidity due to the side effects of the steroids. There is also a high relapse rate,therefore many patients require long term steroid therapy to control their disease which has significant morbidity and mortality. Some patients are or also become steroid resistant. There are studies showing the effectiveness of alkylating agents such as cyclophosphamide but the use of these drugs is limited by their toxicity, including increased rates of infection, cancers and infertility.

Tacrolimus (prograf) is a T-cell specific calcineurin inhibitor that shares similar immunosuppressive actions with cyclosporine A.In other glomerular diseases such as focal segmental glomerulosclerosis and membranous glomerulonephritis, prograf has been shown to be a very effective treatment for proteinuria. This may be due to the immunomodulatory effects on the underlying disease, but there may also be a direct effect of tacrolimus (prograf) on the podocyte, stabilising the actin cytoskeleton and therefore decreasing protein leak.Therefore tacrolimus (prograf) is likely to be effective in reducing proteinuria in minimal change disease.It has also been shown to have a good side effect profile when used to allow the avoidance of steroids in transplantation.This study aims to prospectively study if tacrolimus (prograf) is effective as treatment for minimal change disease compared with standard therapy with steroids, and whether it has advantages in terms of side effect profile and prevention of relapse.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tacrolimus vs Prednisolone for the Treatment Minimal Change Disease
Study Start Date : December 2009
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
Active Comparator: prednisolone
prednisolone tablets
Drug: prednisolone
Prednisolone 1mg/kg maximum 60mg od

Experimental: tacrolimus
tacrolimus tablets
Drug: tacrolimus
tacrolimus0.05mg/kg bd (levels 6-12ng/ml)
Other Name: prograff




Primary Outcome Measures :
  1. Proportion of patients achieving complete remission from nephrotic syndrome (normalisation of serum albumin and urine PCR <50 units) at 8 weeks [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Proportion of patients achieving complete remission from nephrotic syndrome at 16 and 24 weeks [ Time Frame: 16 and 24 weeks ]
  2. Proportion of patients achieving remission who then relapse [ Time Frame: 2 years ]
  3. Nature severity and frequency of adverse events [ Time Frame: 3 years ]
  4. change in baseline glomerular filtration rate [ Time Frame: 3 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with nephrotic syndrome (hypoalbuminaemia and protein creatinine ratio (PCR) > 100units), secondary to minimal change disease.
  • Age over 18.

Exclusion Criteria:

  • Hepatitis B, hepatitis C or HIV infection.
  • Untreated infection.
  • Females who are pregnant, breast feeding, or at risk of pregnancy and not using a medically acceptable form of contraception.
  • Patients who have been treated with immunosuppression over the last 18 months.
  • Patients who have had more than 3 relapses of nephrotic syndrome within 5 years.
  • Any condition judged by the investigator that would cause the study to be detrimental to the patient.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00982072


Contacts
Contact: Megan Griffith, MbChBPhDFRCP 02083835272 m.e.griffith@imperial.ac.uk
Contact: Tom Cairns, MBBS MRCP 02083835272 tom.cairns@nhs.net

Locations
United Kingdom
Hammersmith Hospital Recruiting
London, United Kingdom, W12 OHS
Principal Investigator: Megan Griffith, MBChBFRCPPhD         
Sponsors and Collaborators
Imperial College Healthcare NHS Trust
Investigators
Study Chair: Megan Griffith, MBChBPhDFRCP Imperial College NHS Trust
Principal Investigator: Tom Cairns, MBBSMRCP Imperial College NHS Trust

Responsible Party: Imperial College Healthcare NHS Trust
ClinicalTrials.gov Identifier: NCT00982072     History of Changes
Other Study ID Numbers: 2009-01492-52
2009-01492-52
First Posted: September 22, 2009    Key Record Dates
Last Update Posted: March 6, 2017
Last Verified: March 2017

Keywords provided by Imperial College Healthcare NHS Trust:
nephrotic minimal change tacrolimus prednisolone

Additional relevant MeSH terms:
Nephrosis, Lipoid
Nephrosis
Kidney Diseases
Urologic Diseases
Tacrolimus
Prednisolone acetate
Methylprednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents