Condition category
Urological and Genital Diseases
Date applied
30/07/2018
Date assigned
22/08/2018
Last edited
22/08/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Chronic kidney disease (CKD) is a long-term disease in which the kidneys do not function effectively. The incidence of CKD is much higher in Taiwan than in other countries. End-stage CKD is where almost all kidney function is lost and patients have to rely on dialysis to remove waste products from the blood. Various drugs can be used to slow down deterioration of kidney function, but cannot reverse or cure the progression of CKD. Additionally, patients with CKD can have poor responses to these treatments. An alternative is stem cell therapy, where stem cells (cells capable of developing into other types of cell) to replace damaged kidney cells. The aim of this study is to look at the efficacy of stem cell therapy for reducing the deterioration of kidney function in patients with CKD.

Who can participate?
Patients aged 20-80 years with chronic kidney disease

What does the study involve?
The participants are randomly allocated to one of two groups, either the study group or the control group. The study group will receive standard medication for CKD, along with stem cell therapy, whereas the control group will receive standard medication only.es standard medical therapy. All participants will receive 1 year of follow-up to assess their kidney function.

What are the possible benefits and risks of participating?
The possible benefit of participating is that participants may have improved kidney function as a result. The possible risks of participating are haematoma, contrast-induced nephropathy, malignancy, pain, sepsis and artery dissection.

Where is the study run from?
Kaohsiung Chang Gung Memorial Hospital (Taiwan)

When is the study starting and how long is it expected to run for?
January 2016 to December 2020

Who is funding the study?
Chang Gung Memorial Hospital, Chang Gung Medical Foundation (Taiwan)

Who is the main contact?
Prof. Hon-Kan Yip
han.gung@msa.hinet.net

Trial website

Contact information

Type

Scientific

Primary contact

Prof Hon-Kan Yip

ORCID ID

Contact details

No. 123
Ta Pei Road Niao Sung District
Kaohsiung City
83301
Taiwan

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

TFDA No. 105IND04085

Study information

Scientific title

Application of peripheral blood-derived stem cell/progenitor cell (CD34⁺) therapy on chronic kidney disease: Phase 2 clinical trial

Acronym

Study hypothesis

The peripheral blood-derived stem cell/progenitor cell (CD34⁺) may be a therapeutic option for patients with chronic kidney disease

Ethics approval

Chang Gung Memorial Hospital No. 201600371A0, 19/05/2016, 201600371A0
Taiwan FDA, 23/08/2016, 105IND04085

Study design

Interventional prospective single-center randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Chronic kidney disease

Intervention

Participants will be evenly divided into the intervention group and the controlled group using the envelope method.
Participants in the intervention group will receive standard medication for chronic kidney disease, along with the administration of blood-derived stem cell/progenitor cell (CD34⁺) therapy, while the control group will receive only standard medication.
Standard medication includes angiotensin-converting-enzyme inhibitors (ACEI), angiotensin II receptor blockers (ARB), dopamine reuptake inhibitors (DRI), beta-blockers or calcium channel blockers (CCB) to maintain normal blood pressure within a range of less than 140/90 mmHg.
All participants will receive a 1 year follow up period, where participants will undergo blood biochemistry tests, renal ultrasounds and vital signs will be monitored at 1 week and 3, 6, 9 and 12 months after the intervention period.

Intervention type

Drug

Phase

Phase II

Drug names

Peripheral blood-derived stem cells/progenitor cells (CD34⁺)

Primary outcome measure

Improvement of Ccr (creatinine clearance rate cc/min) from the baseline, assessed using serum creatine levels at the baseline, and after 1 week and 1, 3, 6, 9 and 12 months

Secondary outcome measures

1. Reduction of proteinuria value (albumin/creatinine ratio), assessed at the baseline, and after 1 week and 1, 3, 6, 9 and 12 months. The albumin concentration per creatine level in urea is assessed using the microalbumin test and the urine protein/creatinine ratio is assessed by the Urine Protein-Creatinine Ratio (UPCR) test.
2. Incidence of renal failure (either requiring haemodialysis or causing death) within the 1 year follow-up period

Overall trial start date

31/01/2016

Overall trial end date

31/12/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 20-80 years old
2. Renal failure due to hypertension
3. Receiving optimal medical therapy (received optimal therapy for more than 12 weeks and have been evaluated by a nephrologist. Medication includes ACEI, ARB, DRI, beta-blocker or CCB. Blood pressure is less than 140/90 mmHg)
4. Renal function between chronic kidney disease (CKD) stage III-IV
5. Stable renal function maintained for 1 year before study (creatinine clearance rate between 15-60 ml/min and no significant changes)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

56 subjects (28 subjects for treatment group and 28 subjects for control group)

Participant exclusion criteria

1. Pregnant or breastfeeding
2. Infected with HIV
3. Infected with HBV or HCV
4. Myocardial infarction within 3 months prior to study
5. Heart failure (functional class IV)
6. Malignant or hematological disease
7. Severe disease with lifespan less than 1 year
8. End stage renal disease
9. Creatinine clearance rate less than 15 ml/min
10. Kidney disease on only one side
11. Participating in other clinical trials
12. Unable to receive therapies used in this study
13. Organ transplantation
14. Autoimmune disease

Recruitment start date

01/06/2016

Recruitment end date

31/05/2019

Locations

Countries of recruitment

Taiwan

Trial participating centre

Kaohsiung Chang Gung Memorial Hospital
No.123, Ta Pei Road, Niao Sung District
Kaohsiung
83301
Taiwan

Sponsor information

Organisation

Ministry of Science and Technology, Taiwan

Sponsor details

No. 106 HoPing E. Road Sec.2
Taipei
10622
Taiwan
+886-2-2737-7992
misservice@most.gov.tw

Sponsor type

Government

Website

https://www.most.gov.tw/

Funders

Funder type

Not defined

Funder name

Ministry of Science and Technology (105-2325-B-182A-002 -)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Chang Gung Medical Research Program Grant

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a peer reviewed journal in 2020

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/12/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes